Identity
- Trade Name
- Smart Sense Insulin Syringes FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Device Name
- 1cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct FDA UDI
- Model / Reference
- 103108 FDA UDI
- Description
- 1cc 8mm 31G Insulin Syringe, Sterile, Single-Use, 100ct FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00883968398188 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
- 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
- Total Volume — 1 Milliliter FDA UDINeedle Gauge — 31 Gauge FDA UDILength — 8 Millimeter FDA UDI
Category: Insulin syringe/needle, basic
Smart Sense Insulin Syringes by Kmart Holding Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, basic.
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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
- 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.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kmart Holding Corporation
Sources (1)
- FDA UDI 09bd1d52-416f-4c7a-8d7a-aa1844e2ab61 35 fields · synced May 30, 2026