Identity
- Trade Name
- Comfort Assist Insulin Syringe FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- .5cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 10ct FDA UDI
- Model / Reference
- 053108 FDA UDI
- Description
- .5cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 10ct FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00070030510732 FDA UDI
- 510(k) Number
- K062702 FDA UDI
- FDA Product Code
- FMI FDA UDIFMF FDA UDI
- GMDN Term
- Insulin syringe/needle, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI880.5860 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 8 Millimeter FDA UDINeedle Gauge — 31 Gauge FDA UDITotal Volume — .5 Milliliter FDA UDI
Comfort Assist Insulin Syringe by L Perrigo Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K062702 also covers:
- Smart Sense Insulin Syringes — KMART HOLDING CORPORATION
- Smart Sense Insulin Syringes — KMART HOLDING CORPORATION
- Smart Sense Insulin Syringes — KMART HOLDING CORPORATION
- Smart Sense Insulin Syringes — KMART HOLDING CORPORATION
- Smart Sense Insulin Syringes — KMART HOLDING CORPORATION
- Publix Half Unit Insulin Syringe — PUBLIX SUPER MARKETS, INC.
- Publix Insulin Syringe — PUBLIX SUPER MARKETS, INC.
- Publix Insulin Syringe — PUBLIX SUPER MARKETS, INC.
- Publix Regular Needle Insulin Syringe — PUBLIX SUPER MARKETS, INC.
- Publix Regular Needle Insulin Syringe — PUBLIX SUPER MARKETS, INC.
- Publix Regular Needle Insulin Syringe — PUBLIX SUPER MARKETS, INC.
- Publix Short Needle Insulin Syringe — PUBLIX SUPER MARKETS, INC.
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
- L Perrigo Company
Sources (1)
- FDA UDI 9c96f572-ca77-4bea-9042-ee9f7b8edf73 36 fields · synced Jun 6, 2026