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510(k) Data Aggregation
K Number
K220212Device Name
BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder
Manufacturer
Becton, Dickinson and Company
Date Cleared
2023-03-24
(422 days)
Product Code
JKA, FPA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
Becton, Dickinson and Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BD Vacutainer® Push Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended for use in the general population by healthcare professionals experienced with venipuncture to obtain blood specimens from patients, including those patients with difficult vein access who may have small, fragile, and or non-palpable veins, into evacuated blood collection tubes and/or bottles. When used without the male Luer adapter, the device allows the clinician to obtain a blood specimen from the female Luer connector with a syringe, if necessary. The device can be used by healthcare professionals with infusion experience for short-term, single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and is to remain under the direct supervision of a clinician.
The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
Device Description
The BD Vacutainer® Push Button Blood Collection Set is a sterile, multiple-sample, single-use device used for venipuncture to obtain blood specimens from patients and may be used for the short-term intravenous administration of fluids. The BD Vacutainer® Push Button Blood Collection Set is a winged blood collection set with flexible tubing, a female luer connector and an optional male luer adapter. The BD Vacutainer® Push Button Blood Collection Set also contains a needle protector. The wingset is designed with a safety mechanism to protect against needlesticks. When the button is depressed by the user, the needle fully retracts and is enclosed and locked within the barrel of the device. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
The BD Vacutainer® Push Button Blood Collection Set consists of:
- Stainless steel cannula (Intravenous end and non-patient end of cannula)
- Stainless steel spring
- Hub, front and rear barrel
- Wings (color coded according to needle gauge)
- Tubing
- Female luer connector and an optional male luer adapter
- Intravenous (IV) needle protector (covers the needle before use)
- Pre-attached holder (connected by male luer adapter in some models)
The intravenous needle of the blood collection set is bonded to one end of the hub. The other end of the hub is bonded to the blood collection set tubing, the end of which is then bonded to a female luer connector with an optional attached male luer adapter. Some models come with a pre-attached holder connected to the male luer adapter for user convenience. A spring is loaded onto the front barrel of the hub. Once the sample is collected, and without removing the needle from the patient vein, the user depresses the raised push button on top of the hub which activates the spring mechanism to automatically retract the needle from the device. In this retracted (locked) position, the IV point of the needle is fully contained within the body of the device. This will prevent the needle from coming out of the front barrel once it has retracted as well as preventing accidental overriding of the safety feature.
The blood collection set with a male luer adapter contains threads for attachment to a Vacutainer® Brand Needle Holder, and a non-patient cannula for blood collection into evacuated blood collection tubes and/or blood culture bottles. For models without the pre-attached holder, the user is instructed to attach a holder before using the device. The pre-attached holder models come with the BD Vacutainer® Brand Holder pre-attached for user convenience. The non-patient end cannula of the luer adapter has a sleeve that recovers over the cannula to stop blood flow in between collection of multiple tubes.
When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe, if necessary. The device can be used for short-term, single infusions (up to 2 hours) with consideration given to patient size and appropriateness for the solution being infused.
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K Number
K222559Device Name
BD BACTEC Myco/F Lytic Culture Vials
Manufacturer
Becton, Dickinson and Company
Date Cleared
2023-03-24
(212 days)
Product Code
MDB
Regulation Number
866.2560Why did this record match?
Applicant Name (Manufacturer) :
Becton, Dickinson and Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BD BACTEC Myco/F Lytic culture medium when used with the BD BACTEC fluorescent series instruments is a nonselective culture medium to be used as an adjunct to aerobic blood culture media for the qualitative culture and recovery of mycobacteria, yeast and fungi from blood. This medium may also be used for the culture of sterile body fluids when veast or fungi are suspected.
Device Description
BD BACTEC Myco/F Lytic culture medium is a Middlebrook 7H9 and Brain Heart Infusion broth formulation for the recovery of mycobacteria from blood specimens, and yeast and fungi from blood and sterile body fluids. Specific modifications were made to enhance the growth and recovery of mycobacteria, yeast and fungi. These modifications include ferric ammonium citrate to provide an iron source for specific strains of mycobacteria and fungi, the addition of saponin as a blood lysing agent, and the addition of specific proteins and sugars to provide nutritional supplements. Each vial contains a sensor which can detect decreases in oxygen concentration in the vial resulting from microorganism metabolism and growth. The sensor is monitored by the BD BACTEC fluorescent series instrument for increasing fluorescence, which is due to the decrease in oxygen. A positive determination indicates the presumptive presence of viable microorganisms in the vial.
BD BACTEC Myco/F Lytic Culture Vials are supplied in a carton containing 50 vials. It is a nonsterile product.
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K Number
K223286Device Name
BD AutoShield Duo Pen Needle
Manufacturer
Becton, Dickinson and Company
Date Cleared
2022-12-28
(64 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Becton, Dickinson and Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BD AutoShield Duo™ Pen Needle is intended for use with pen injector devices for the subcutaneous injection of drugs.
The product has two safety shields, which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.
Device Description
The pen needle assembly consists of a double-ended cannula that is assembled onto an injection molded hub. The internal threads allow the subject device to be screwed onto a pen injector device, further enabling the non-patient end of the cannula to penetrate through the septum of the pen injector cartridge.
The patient and non-patient ends of the cannula are visible prior to attachment to the pen injector device. The BD AutoShield Duo™ Pen Needle has safety mechanisms on both the patient and non-patient ends of the needle, allowing the needle to be shielded and locked after use, which is designed to reduce the occurrence of accidental needle-stick injuries. The BD AutoShield Duo™ Pen Needle is a single use disposable device and is provided sterile. The subject device is non-toxic and non-pyrogenic.
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K Number
K213955Device Name
0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
Manufacturer
Becton, Dickinson and Company
Date Cleared
2022-07-16
(211 days)
Product Code
QTI, OTI
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Becton, Dickinson and Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.
Device Description
BD PosiFlush™ SafeScrub is a sterile, single use pre-filled saline syringe with integrated Disinfection Unit (DU). The polypropylene syringe contains 0.9% sodium chloride (USP) solution with a tip cap that is modified at the distal end to accommodate DU. The DU has high density polyethylene housing with 70% Isopropyl Alcohol (IPA) solution in low density polyethylene foam. The pre-filled syringe with modified syringe tip cap is sterilized by moist heat and the DU is sterilized by gamma irradiation. The subject device is available only in 10mL syringe configuration.
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K Number
K193190Device Name
BD PureHub Disinfecting Cap
Manufacturer
Becton, Dickinson and Company
Date Cleared
2020-11-09
(356 days)
Product Code
QBP, OBP
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Becton, Dickinson and Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BD PureHub™ Disinfecting Caps are intended to be used as a disinfecting cleaner for swabbable needle-free luer connectors prior to access and to act as a physical barrier between line accesses.
BD PureHub™ Disinfecting Cap will disinfect the needle-free luer connector one (1) minute after application and act as a physical barrier for up to seven (7) days, if not removed.
Device Description
BD PureHub™ Disinfecting Cap is a sterile, single use disinfectant cap designed for needle-free Luer connectors. It has high-density polyethylene housing and polyester urethane sponge saturated with 70% Isopropyl Alcohol (IPA) solution. PureHub™ disinfects needle-free Luer connectors one minute after application and acts as a physical barrier for up to seven days, if not removed. It is available in two packaging configurations - Bulk Single Unit and IV Pole Strip.
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