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510(k) Data Aggregation
K Number
K222224Device Name
SurgiLance® Safety Lancet
Manufacturer
MediPurpose Pte. Ltd.
Date Cleared
2022-09-22
(59 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
MediPurpose Pte. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SurgiLance® Safety Lancet is a puncture device to obtain micro blood samples. The SurgiLance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury. Single patient use only.
Device Description
The SurgiLance® Safety Lancet is a needle or blade device used to prick a patient's finger to draw a micro-sample of blood which can then be tested for an array of diagnostic assays. Lancets are commonly used in hospitals, clinics, physician offices, laboratories, OB/GYN practices, oncology departments, emergency medical services, nursing homes and blood banks. The outside plastic casing is designed to be ergonomic for the user and compatible with the test site, usually a human finger. The device is available with either a needle or blade, each with different depths of penetration, to provide optimal blood flow for different applications and skin types. The SurgiLance® Safety Lancet comes in seven (7) models: two low flow, two medium flow, and three high flows. The seven models are differentiated by their casing color. SurgiLance® Safety Lancets are safely retracted and concealed before and after use. The user simply removes the protective cap, places the red raised platform end onto the patient's test site, and gently pushes the lancet down against the test site to activate the lancet mechanism. Once the lancet is used, it is rendered inoperative, providing added safety for patient and clinician. The device is discarded in a sharps container after use. SurgiLance Safety Lancets are provided sterile and are single patient use only. They are sterilized using irradiation (R) sterilization method.
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K Number
K130132Device Name
BABYLANCE HEEL INCISION DEVICE
Manufacturer
MEDIPURPOSE PTE. LTD.
Date Cleared
2013-02-11
(24 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
MEDIPURPOSE PTE. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The babyLance® is an incision device to obtain a blood sample from the heel of newborn and preemie infants. The babyLance® has a sharps prevention feature to protect the user from a sharps injury.
Device Description
The MediPurpose babyLance® Heel Incision Device is designed to be a one handed automated incision device for use in heel sticks of newborn and neonatal infants (also called preemie infants). A heel stick is a procedure in which a newborn baby's heel is pricked for blood collection for use in newborn screening tests. The outside plastic casing is designed to be ergonomic for the user and compatible with an infant's foot. The user breaks off the trigger lock from the device, the device is positioned on the newborn's heel and the user depresses the trigger to activate the blade to make an incision. Once the blade has been triggered, the blade is automatically retracted within the housing. The device is discarded in a sharps container after use.
The babyLance® comes in two models, preemie and newborn. The preemie model is to be used on pre term neonates, while the newborn model is for full term neonates. The two models are differentiated by color.
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K Number
K110062Device Name
MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG
Manufacturer
MEDIPURPOSE PTE. LTD.
Date Cleared
2011-09-01
(234 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEDIPURPOSE PTE. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MediPlus-Foam™ AG, MediPlus-ComfortFoam™ AG, and MediPlus-SuperFoam™ AG Dressings are indicated for exudate absorption and the management of partial to full thickness wounds. Some typical wounds are:
- Ulcers (venous, arterial, diabetic) .
- Pressure Sores ●
- . Donor Sites
- Surgical Incisions .
- Surgical Excisions .
- . Burns (1st and 2nd degree)
Device Description
The MediPlus-Foam™ AG Dressings product line is a multi-layered, sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth elastic and breathable PU foam sandwiched in between a breathable PU film and a silver net layer acting as an ... antimicrobial barrier. The product line is available in different sizes. The MediPlus-SuperFoam™ AG Dressings product line has slightly thicker PU foam and is easier to bend for covering wound areas such as elbows or heels.
The MediPlus-ComfortFoam™ AG Dressings is a multi-layered, sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth elastic and breathable PU foam sandwiched in between a breathable PU film coated with acrylic adhesive and extends to act as a border adhesive film to allow application without need for secondary dressing or fixation bandage. The silver net layer acts as an antimicrobial barrier. MediPlus-ComfortFoam AG is useful for body sites where applying a secondary dressing or fixation bandage is not practicable or not desired by the user.
MediPlus-Foam AG, MediPlus-ComfortFoamAG, andMediPlus-SuperEoam AG Dressingsare used as an antimicrobial barrier for partial and full-thickness wounds such as builts, donor sites and graft recipient sites that are judged to be at risk from infection. The product features include: managing moisture level in the wound environment, controlled silver release, and the product mesh facilitates the passage of fluids/exudates through the dressing into the PU foam for adsorption. The dressings can remain on the wound for five to seven (5-7) days dependent on the amount of wound exudates.
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K Number
K101145Device Name
SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250
Manufacturer
MEDIPURPOSE PTE. LTD.
Date Cleared
2010-10-21
(181 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
MEDIPURPOSE PTE. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SurgiLance® Safety Lancet is a puncture device to obtain micro blood samples. The SurgiLance Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury.
Device Description
The MediPurpose SurgiLance® Safety Lancets is a needle or blade device used to prick a patient's finger to draw a micro-sample of blood which can then be tested for an array of diagnostic assays. Point-of-Care (POC) tests currently using micro-sample quantities of whole blood include glucose, cholesterol, HIV, Hepatitis, A1C, Allergies, Lactate, HgB, H.Pvlori. Creatinine, Mono, PT, D-Dimer, Anemia, Thyroid, Triglycerides, Ketones, Prostate, IgE. Chagas and more. Lancets are commonly used in hospitals, clinics, physician offices, laboratories, OB/GYN practices, oncology departments, emergency medical services, nursing homes and blood banks. The outside plastic casing is designed to be ergonomic for the user and compatible with the test site, usually a human finger. The device is available with either a needle or blade, each with different depths of penetration, to provide optimal blood flow for different applications and skin types.
The SurgiLance® Safety Lancet is safely retracted and concealed before and after use. The user simply removes the protective cap, places the red raised platform end onto the patient's test site, and gently push the lancet down against the test site to activate the lancet mechanism. Once the lancet is used, it is rendered inoperative, providing added safety for patient and clinician. The device is discarded in a sharps container after use.
The SurgiLance® Safety Lancet comes in six models: two low flow, one medium flow, one medium-high flow, and two high flows. The six models are differentiated by their casing color.
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K Number
K101417Device Name
BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200
Manufacturer
MEDIPURPOSE PTE. LTD.
Date Cleared
2010-10-19
(152 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
MEDIPURPOSE PTE. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The babyLance™ is an incision device to obtain a blood sample from the heel of newborn and preemie infants. The babyLance™ has a sharps prevention feature to protect the user from a sharps injury.
Device Description
The MediPurpose babyLance™ Heel Incision Device is designed to be a one handed automated incision device for use in heel sticks of newborn and neonatal infants (also called preemie infants). A heel stick is a procedure in which a newborn baby's heel is pricked for blood collection for use in newborn screening tests. The outside plastic casing is designed to be ergonomic for the user and compatible with an infant's foot. There are three integrated components to the sharps prevention feature: a) a locking mechanism to prevent accidental activation of the device because the user breaks off the trigger locking mechanism from the device, b) once the locking mechanism has been removed, the device is positioned on the newborn's heel and the user depresses the trigger to activate the blade to make an incision, c) once the blade has been triggered, the device is immediately removed from the infant's foot which retracts the blade. The device is discarded in a sharps container after use.
The babyLance™ comes in two models, preemie and newborn. The preemie model is to be used on pre term neonates, while the newborn model is for full term neonates. The two models are differentiated by color.
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