FDA.reportPublic FDA data

MEDIVENA, LLC

Matched from indexed company URL: MediVena, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30133310673013331067MEDIVENA, LLC1Y2026-01-011 Glenlake Parkway Suite 700 Atlanta GA US 30328
30154852833015485283MEDIVENA SP. Z O.O.1N2026-01-01Aleja Jana Pawla II 27 Warszawa Mazowieckie PL 00-867

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810008210147ONE-CARE Safety Lancets - ONE-CARE Safety Lancets 21G x 2.4mm, LowFlow, are sterile, single-use devices designed for capillary blood sampling, ensuring safety, precision, and comfort during the procedure.4045142586info@medivena.com
00810008211502ONE-CARE Pen Needles - The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a compatible insulin pen injector. It consists of a fine, thin-wall needle with an integrated safety cap and a universal screw-on or snap-on connection for compatibility with most insulin pen devices.4045142586info@medivena.com
00810008214015ONE-CARE Pen Needles - The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a compatible insulin pen injector. It consists of a fine, thin-wall needle with an integrated safety cap and a universal screw-on or snap-on connection for compatibility with most insulin pen devices.4045142586info@medivena.com
00810008214275ONE-CARE Pen Needles - The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a compatible insulin pen injector. It consists of a fine, thin-wall needle with an integrated safety cap and a universal screw-on or snap-on connection for compatibility with most insulin pen devices.4045142586info@medivena.com
00810008215654ONE-CARE Insulin Syringes - The ONE-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.4045142586info@medivena.com
00810008215685ONE-CARE Insulin Syringes - The ONE-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.4045142586info@medivena.com
00810008217221GLUCO-CARE PLUS Pen Needles - The insulin pen needle is a sterile, single-use medical device designed for subcutaneous insulin delivery when attached to a compatible insulin pen injector. It consists of a fine, thin-wall needle with an integrated safety cap and a universal screw-on or snap-on connection for compatibility with most insulin pen devices4045142586info@medivena.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3268281997691970K222408Disposable Safety LancetFMK2022-11-29
3268281133916286K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)FMK2022-10-03
3268281789990150K222090Safety LancetFMK2022-09-30
3268281546116395K221839LancetFMK2022-09-19
3268281952952338K221178Disposable Insulin Pen NeedleFMI2022-11-17
3268281295100129K220614MEDOJECT fine Pen NeedlesFMI2022-06-15
3268281116902888K213183Safety Insulin Pen NeedlesFMI2022-10-14
3268281257153261K201044CHIRANA Insulin SyringesFMF2022-01-18
3268281312611001K172763Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with HolderJKA2018-06-04
3268281661766550K151991
3268282047633433K133059INSULIN PEN NEEDLEFMI2014-02-25
3268281683807045K113091

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMK42022-11-29
FMI42022-11-17
FMF12022-01-18
JKA12018-06-04

GUDID#

ONE-CARE Luer-Lock Syringes - The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

MediVena, LLC

2025-06-18

ONE-CARE Luer-Lock Syringes - The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

MediVena, LLC

2025-06-18

ONE-CARE Luer-Lock Syringes - The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

MediVena, LLC

2025-06-18

ONE-CARE Luer-Lock Syringes - The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

MediVena, LLC

2025-06-18

ONE-CARE Luer-Lock Syringes - The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

MediVena, LLC

2025-06-18

ONE-CARE Luer-Lock Syringes - The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

MediVena, LLC

2025-06-18

ONE-CARE Luer-Lock Syringes - The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

MediVena, LLC

2025-06-18

ONE-CARE Luer-Lock Syringes - The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

MediVena, LLC

2025-06-18

ONE-CARE Luer-Lock Syringes - The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

MediVena, LLC

2025-06-18

ONE-CARE Luer-Lock Syringes - The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

MediVena, LLC

2025-06-18

ONE-CARE Luer-Lock Syringes - The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

MediVena, LLC

2025-06-18

ONE-CARE Luer-Lock Syringes - The ONE-CARE Luer Lock syringe is a sterile, single-use medical device designed for the accurate aspiration and administration of fluids. It is composed of a transparent barrel with graduated markings for precise volume measurement, a plunger for controlled fluid delivery, and a Luer Lock connector that allows secure and leak-resistant attachment to compatible needles, catheters, or other devices with a Luer fitting. The syringe is available in various volumes (e.g., 1 mL, 3 mL, 5 mL, 10 mL, 20 mL). The device is intended for use in general medical, surgical, and laboratory applications.

MediVena, LLC

2025-06-18

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