GLUCO-CARE Insulin Syringes

FDA UDI

Class II (US FDA UDI)

by MediVena, LLC

Identity

Trade Name: GLUCO-CARE Insulin Syringes FDA UDI
Generic Name: Insulin syringe/needle, basic FDA UDI
Device Name: The GLUCO-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. FDA UDI
Model / Reference: GLUCO-CARE Insulin Syringes 0.3ml/cc, 30G x 5/16"(8mm), U-100, 10/bg x 10, 100/b FDA UDI
Description: The GLUCO-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. FDA UDI

Identifiers

Catalog Number: 2242 FDA UDI
Primary DI / UDI-DI: 00810008215791 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Insulin syringe/needle, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

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Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Total Volume — 0.3 Milliliter FDA UDI
Needle Gauge — 30 Gauge FDA UDI
Length — 8 Millimeter FDA UDI

Category: Insulin syringe/needle, basic

GLUCO-CARE Insulin Syringes by MediVena, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: MediVena, LLC

Sources (1)

FDA UDI 3674ff46-77a9-4e62-90df-fed493523fc4 37 fields · synced May 30, 2026