Identity
- Trade Name
- AIMSTRIP PLUS LANCETS FDA UDI
- Generic Name
- Home-use blood glucose spot-check system FDA UDI
- Device Name
- Lancets (sterile) for use with Blood Glucose Test Strips & meter for testing blood glucose levels FDA UDI
- Model / Reference
- 37311 FDA UDI
- Description
- Lancets (sterile) for use with Blood Glucose Test Strips & meter for testing blood glucose levels FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00695684373115 FDA UDI
- FDA Product Code
- NBW FDA UDI
- GMDN Term
- Home-use blood glucose spot-check system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
Category: Home-use blood glucose spot-check system
Aimstrip Plus Lancets by Germaine Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home-use blood glucose spot-check system.
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- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Mckesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Mckesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- VivaGuard Ino Blood Glucose Test Strips — ABOUND Diagnostics, Inc · Class II
- D-Care — HUDSON SCIENTIFIC LLC · 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
- Germaine Laboratories, Inc.
Sources (1)
- FDA UDI 62bdc17c-93cf-4d23-ac64-15ee08b968dd 33 fields · synced Jun 7, 2026