(264 days)
Not Found
No
The device description and performance studies focus on material properties, sterilization, packaging, and physical performance characteristics of a standard intermittent catheter. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes.
The device is intended for "Intermittent drainage of the urinary bladder...due to conditions causing urinary retention or dysfunction of the urinary system," which describes a therapeutic purpose.
No
This device is an intermittent urethral catheter designed for intermittent drainage of the urinary bladder, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like a flexible tube, funnel, water sachet, and handling sleeve, all made from plastic materials. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The description clearly states that the device is a "hydrophilic, intermittent, urethral catheter" used for the "intermittent drainage of the urinary bladder." This is a physical device used to facilitate a bodily function (urination) and is inserted into the body.
- No Mention of Testing Samples: There is no indication that this device is used to analyze samples taken from the body. Its purpose is to drain urine directly from the bladder.
Therefore, this device falls under the category of a medical device used for treatment or management of a condition, not an in vitro diagnostic used for testing samples.
N/A
Intended Use / Indications for Use
Intermittent drainage of the urinary bladder of Adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.
The target population for GC Air for Men is male adults and includes Transitional Adolescents B (18 year old to less than 22 years old but treated like adult).
Product codes
GBM
Device Description
GC Air for Men is a sterile, single use, disposable, hydrophilic, intermittent, urethral catheter. It is designed for portability, ease of use and discreet disposal, with FeelClean™ technology for superior comfort and less sticky residue. The catheter comprises of a flexible tube and color-coded funnel, both made from plastic materials (Polyvinyl Chloride; PVC). The catheter tube is made using thermoplastic elastomer (TPE) with a hydrophilic additive in the base material which when wetted activates and lubricates the catheter.
Catheters are individually packed into a sealed foil primary pouch along with a sterile (E-Beam) water sachet and handling sleeve, prior to secondary and tertiary packing and sterilization by X-Ray irradiation. The water sachet is provided for wetting of the hydrophilic surface and is burst at the point of use. The handling sleeve is provided to minimize touching the catheter shaft directly during insertion and retraction. The following product sizes and tips are available:
Size: CH08/10/12/14/10/16/18
Tips: Nelaton/straight or Coudè /Tiemann
Effective Length: 405mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary bladder, urethra
Indicated Patient Age Range
Adults, Transitional Adolescents B (18 year old to less than 22 years old but treated like adult).
Intended User / Care Setting
GC Air for Men target users will be those who are able self-catheterize and have no or minimal dexterity impairment. However, users with dexterity impairments are not excluded from the intended users should they wish to use the device with assistance from others.
Additional users are healthcare professionals including nurses, and/or caregivers and family members who help patients with catheterization.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing for GC Air for Men was conducted per applicable sections of voluntary and FDA consensus standards:
Sterilization validation was performed by conducting dose setting per ISO 11137-1:2015
Biocompatibility testing (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity and Subacute/Subchronic Systemic Toxicity) according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2020)
Sterile packaging in accordance with ISO 11607-1 2019 and ISO 11607-2 2019
Accelerated and Real Time aged shelf life testing according to ASTM F1980-16
Performance Testing of Shipping Containers and Systems according to ASTM D4169-16
Packaging integrity testing according to ASTM F2096-11
Flow rate and Tensile testing performed in accordance with ISO 20696:2018
Coefficient of friction according to ASTM D1894:2014
Tensile testing in accordance with ISO 20696:2018
Conclusion: The performance and biocompatibility testing demonstrate that the GC Air for Men poses no additional risk to safety and efficacy than the predicate device GC Glide. All the parameters are similar for the GC Air for Men; therefore, the GC Air for Men is determined to be substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 22, 2022
ConvaTec Limited Louise Hollywood Principal Regulatory Affairs Specialist GDC, First Avenue, Deeside industrial Park Deeside, Flintshire CH5 2NU United Kingdom
Re: K213283
Trade/Device Name: GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: May 11, 2022 Received: May 23, 2022
Dear Louise Hollywood:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Expiration Date: 06/30/2023
See PRA Statement below.
Form Approved: OMB No. 0910-0120
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
Indications for Use (Describe)
Intermittent drainage of the urinary bladder of Adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system
The target population for GC Air for Men is male adults and includes Transitional Adolescents B (18 year old to less than 22 years old but treated like adult).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (6/20)
Page 1 of 1
3
Image /page/3/Picture/1 description: The image shows the logo for Convatec. The logo consists of a purple abstract shape on the left and the word "convatec" in purple on the right. Below the word "convatec" is the phrase "- forever caring -" in a smaller font.
Section 5 Traditional 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92 (c).
- Submitted bv: ConvaTec Limited. GDC, First Avenue Deeside Industrial Park Deeside Flintshire CH5 2NU UK
- Contact Person: Louise Hollywood Principle Regulatory Affairs Specialist ConvaTec Ltd. GDC, First Avenue, Deeside industrial Park Deeside, Flintshire, CH5 2NU, UK louise.hollywood@convatec.com Tel: +44(0) 7776 662499
- Date of Summary: 22 June 2022
- Trade Name: GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
- Common Name: Catheter, urethral
- Regulation Name: Urological Catheter and accessories
- Regulation Number: 21 CFR 876.5130
- Classification: Class II
- Product Code: GBM (catheter, urethral)
- Panel: Gastroenterology and Urology
- Predicate Device: GentleCath Glide Intermittent Catheter, K181206 The predicate device has not been subject to a design related recall
4
Image /page/4/Picture/1 description: The image shows the logo for Convatec. The logo consists of a circular graphic on the left and the word "convatec" on the right. The graphic is a stylized representation of a sphere surrounded by curved shapes in shades of pink and purple. Below the word "convatec" is the tagline "- forever caring -" in a smaller font.
-
GC Air for Men is a sterile, single use, disposable, hydrophilic, Device Description: intermittent, urethral catheter. It is designed for portability, ease of use and discreet disposal, with FeelClean™ technology for superior comfort and less sticky residue. The catheter comprises of a flexible tube and color-coded funnel, both made from plastic materials (Polyvinyl Chloride; PVC). The catheter tube is made using thermoplastic elastomer (TPE) with a hydrophilic additive in the base material which when wetted activates and lubricates the catheter.
Catheters are individually packed into a sealed foil primary pouch along with a sterile (E-Beam) water sachet and handling sleeve, prior to secondary and tertiary packing and sterilization by X-Ray irradiation. The water sachet is provided for wetting of the hydrophilic surface and is burst at the point of use. The handling sleeve is provided to minimize touching the catheter shaft directly during insertion and retraction. The following product sizes and tips are available: -
· Size: CH08/10/12/14/10/16/18
-
· Tips: Nelaton/straight or Coudè /Tiemann
-
· Effective Length: 405mm
Intended use: To provide an intermittent pathway for drainage of fluids from the urinary bladder. The catheter is inserted through the urethra.
Indication for Use
Intermittent drainage of the urinary bladder of Adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.
The Intended use population
Adult males who need assistance with bladder drainage due to conditions causing dysfunction of the urinary system.
The target population for GC Air for men is male adults and includes Transitional Adolescents B (18-year-old to less than 22 years old but treated like adult). The selection of the CH size of the catheter is based on the size of the patient and is prescribed by a health care professional. The length of the catheter meets the requirements of EN ISO 20967:2018 for the minimum effective shaft length (275 mm) for males.
Additional users are healthcare professionals including nurses, and/or caregivers and family members who help patients with catheterization.
5
Image /page/5/Picture/1 description: The image shows the ConvaTec logo. The logo consists of a circular graphic on the left and the word "convatec" on the right. The graphic is a stylized representation of a sphere surrounded by curved shapes in shades of pink and purple. Below the word "convatec" is the tagline "- forever caring -" in a smaller font.
GC Air for Men target users will be those who are able self-catheterize and have no or minimal dexterity impairment. However, users with dexterity impairments are not excluded from the intended users should they wish to use the device with assistance from others.
| Performance Testing: | Performance testing for GC Air for Men was conducted per applicable
sections of voluntary and FDA consensus standards: |
| ----------------------------- | --------------------------------------------------------------------------------------------------------------------------- |
|---|
- . Sterilization validation was performed by conducting dose setting per ISO 11137-1:2015
- . Biocompatibility testing (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity and Subacute/Subchronic Systemic Toxicity) according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2020)
- Sterile packaging in accordance with ISO 11607-1 2019 and ISO . 11607-2 2019
- Accelerated and Real Time aged shelf life testing according to ASTM F1980-16
- Performance Testing of Shipping Containers and Systems ● according to ASTM D4169-16
- Packaging integrity testing according to ASTM F2096-11 ●
- Flow rate and Tensile testing performed in accordance with ISO ● 20696:2018
- Coefficient of friction according to ASTM D1894:2014
- Tensile testing in accordance with ISO 20696:2018 ●
- Conclusion: The performance and biocompatibility testing demonstrate that the GC Air for Men poses no additional risk to safety and efficacy than the predicate device GC Glide. All the parameters are similar for the GC Air for Men; therefore, the GC Air for Men is determined to be substantially equivalent to the predicate device.
6
Image /page/6/Picture/1 description: The image shows the logo for Convatec. The logo consists of a purple abstract circular design on the left and the word "convatec" in purple on the right. Below the word "convatec" is the phrase "- forever caring -" in a smaller font size.
Substantial Equivalence discussion
The following table compares the similarities and differences between the subject GC Air for Men and the predicate GC Glide and outlines the product characteristics and specifications which form the basis of the substantial equivalence discussion. The intended use, technological characteristics and principles of operation of GC Air for Men remains the same as those of the predicate device.
| Table 1:Device Comparison Table | |
|---|---|
| --------------------------------- | -- |
| Parameter | Subject Device | Predicate Device
(K181206) | Comparison | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | GentleCath Air for Men
Hydrophilic Intermittent
Urinary Catheter | GentleCath Glide
Intermittent
Catheter
(Adult male product
variants only) | Similarities | Differences |
| FDA Product Code | GBM | GBM | All devices are
the same | None |
| FDA Classification
Regulation | 21 CFR 876.5130 | 21 CFR 876.5130 | All devices are
the same | None |
| Regulatory Class | Class II | Class II | All devices are
the same | None |
| Device description | A sterile, single use,
disposable, hydrophilic,
intermittent urethral
catheter. It is designed for
portability, ease of use and
discreet disposal with
FeelClean™ technology
for superior comfort and
less sticky residue. The
catheter comprises of a
flexible tube and color
coded funnel, both made
from plastic materials
(Polyvinyl Chloride; PVC).
The catheter tube is made
using thermoplastic
elastomer (TPE) with a
hydrophilic additive in the
base material which when
wetted activates and
lubricates the catheter | A hydrophilic urinary
catheter is a flexible
tubular device that is
inserted through the
urethra and used to
pass fluids from the
bladder. It includes a
substance that makes
the surface slippery
when it comes into
contact with water.
The catheter is
provided together with
a sterile water sachet
for lubrication | The devices are
equivalent | GC Air for Men is
designed for portability,
ease of use and discreet
disposal. The catheter is
comprised of equivalent
materials, including a
hydrophilic additive. |
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Image /page/7/Picture/1 description: The image contains the logo for Convatec. The logo features a circular graphic on the left, composed of curved shapes in shades of purple and pink, resembling a stylized flower or abstract design. To the right of the graphic is the word "convatec" in a bold, purple sans-serif font, and below that, the tagline "- forever caring -" is written in a smaller, lighter font.
| Intended use /
Indication for Use | To provide an intermittent
pathway for drainage of
fluids from the urinary
bladder. The catheter is
inserted through the
urethra.
For Male adult use
including Transitional
Adolescents B | Intermittent catheters are
indicated for routine
transient drainage of the
bladder. The catheter is
inserted through the
urethra.
For adult use including
Transitional Adolescents
B | All devices
are the same | Glide is available for
male, female adults as
well as pediatrics
(Children, adolescents,
and transitional
adolescents B). Device
comparison is being
made on predicate
adult, male variants
only. Air is for Adult
males only |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cautions | Single use
Prescription only | Single use
Prescription only | All devices
are the same | None |
| Tube Material | TPE hydrophilic M6906-02
(Polyolefin Based
Synthetic Thermoplastic
Elastomer (TPE) M6504 as
a base material and
Techsurf™ 15560 for
hydrophilic additive) | TPE hydrophilic M6906-
01 (Polyolefin Based
Synthetic Thermoplastic
Elastomer (TPE) M6504
as a base material and
Techsurf™ 15560 for
hydrophilic additive) | All devices
are equivalent | A different but
equivalent hydrophilic
additive in the
granulate used for the
extrusion of the
catheter tube is used in
the subject device
compared to the
cleared predicate. The
formulation change
does not alter the
chemical or physical
properties of the
medical device in its
final finished form. |
| Funnel Material | PVC + DEHT | PVC + DEHT | All devices
are the same | None |
| Glue for assembly | Loctite | Loctite | All devices
are the same | None |
| Biocompatibility | Evaluation and testing
• within risk
management process
ISO 10993-1
• Cytotoxicity ISO
10993-5
• Sensitization
ISO10993-10
• Skin Irritation
ISO10993-10
• Sensitization
ISO10993-10
• Skin Irritation
ISO10993-10 | Evaluation and
• testing within risk
management
process ISO 10993-
1
• Cytotoxicity
ISO 10993-5
• Sensitization
ISO10993-10
• Skin Irritation
ISO10993-10
• Genotoxicity
ISO10993-3
• Subchronic Toxicity
ISO 10993-11
• EtO sterilization
residuals ISO
10993-7 | All devices
are the same | Biological equivalency
between GC Glide and
GC Air for Men was
established by
providing evidence of
Material Equivalency
through Chemical and
Physical Equivalency as
well as endpoint
equivalency |
| Principal of
operation - short
description of use | Squeeze water pocket
Peel pack open
Insert catheter
Empty bladder
Withdraw catheter
Dispose device | Squeeze water pocket
Peel pack open
Insert catheter
Empty bladder
Withdraw catheter
Dispose device | All devices
are the same | None |
| Length
(mm) | Male: 405mm | Male: 405mm | All devices
are the same | None |
| FR Size | Male: CH08-CH16 | Male: CH08-CH18 | All devices
are the same | Glide is available for
male, female adults as
well as pediatrics
(Children, adolescents,
and transitional
adolescents B). Device
comparison is being
made on predicate
adult, male variants
only. Air is for Adult
males only |
| Funnel color
indicating size | CH08: Blue
CH10: Black
CH12: White
CH14: Green
CH16: Orange
CH18: Red | CH08: Blue
CH10: Black
CH12: White
CH14: Green
CH16: Orange
CH18: Red | All devices
are the same | None |
| Catheter tube -
outer diameter
(mm ±0.33) | CH08: 2.67
CH10: 3.33
CH12: 4.00
CH14: 4.67
CH16: 5.33
CH18: 6.00 | CH08: 2.67
CH10: 3.33
CH12: 4.00
CH14: 4.67
CH16: 5.33
CH18: 6.00 | All devices
are the same | None |
| Eyelets | Smooth eyelet | Smooth eyelet | All devices
are the same | None |
| Eyelet position | Staggered | Staggered | All devices
are the same | None |
| Tip types in range | Straight / Nelaton
Tiemann / Coudè | Straight / Nelaton
Tiemann / Coudè | All devices
are the same | None |
| No-touch
functionality | Sleeve | Sleeve | All devices
are the same | None |
| Liquid for wetting | Sterile water | Sterile water | All devices
are the same | None |
| Sticky-dot | Double sided adhesive dot | Double sided adhesive
dot | All devices
are the same | None |
| Primary packaging | a three-sided seal bag with
zipper, composed of
12PET/ADH/LLDPE60
material | Paper and film peel pack | Devices are
different | GC Air for men is
packed in foil pack that
is suitable for X- Ray
sterilization. GC Glide
is packed in a paper
film peel pack that is
suitable for EO
sterilization. |
| Secondary
packaging | Corrugated board, Box
quantity: 30 | Corrugated board, Box
quantity: 30 | All devices
are the same | None |
| Shipper case | Corrugated board | Corrugated board | All devices
are the same | None |
| Sterilization
process | X-Ray | EO | Devices are
different | Devices are sterilized
by different methods,
but both achieve a
SAL of 10-6 |
| Shelf life | 18 Months | 18 months | All devices
are the same | None |
8
Image /page/8/Picture/1 description: The image contains the logo for Convatec. The logo consists of a purple and pink abstract circular design on the left, followed by the word "convatec" in purple, and the tagline "- forever caring -" in a smaller font size below the word "convatec". The logo is clean and modern, with a focus on the company name and its caring mission.
9
Image /page/9/Picture/1 description: The image shows the logo for Convatec. The logo consists of a circular graphic on the left and the word "convatec" on the right. The graphic is a stylized representation of a sphere surrounded by curved shapes in shades of pink and purple. Below the word "convatec" is the tagline "- forever caring -" in a smaller font.