Identity
- Trade Name
- GLUCO-CARE PLUS Pen Needles FDA UDI
- Generic Name
- Insulin syringe/needle, safety FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 3027-GLUCO-CARE PLUS Pen Needles, 31G x 6mm, Blue, 100ct, 50bx/cs FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Catalog Number
- 3027 FDA UDI
- Primary DI / UDI-DI
- 00810008217245 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Insulin syringe/needle, safety FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 31 Gauge FDA UDILength — 6 Millimeter FDA UDI
Category: Autoinjector needleInsulin syringe/needle, safety
GLUCO-CARE PLUS Pen Needles by MediVena, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Insulin syringe/needle, safety.
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- Disposable Insulin Syringe — Berpu Medical Technology Co., Ltd · Class II
- RELI — MYCO MEDICAL SUPPLIES INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
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 2bb9fba9-3270-4985-8d78-f7b637644717 37 fields · synced May 30, 2026