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GL GoodLife Blood Glucose Test Strip AC (50ct in foil)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- GL GoodLife Blood Glucose Test Strip AC (50ct in foil) FDA UDI
- Generic Name
- Home-use/point-of-care blood glucose/blood pressure monitoring system FDA UDI
- Device Name
- GoodLife AC Blood Glucose Test Strips FDA UDI
- Model / Reference
- AC11-Foil FDA UDI
- Description
- GoodLife AC Blood Glucose Test Strips FDA UDI
Identifiers
- Catalog Number
- 3K-01-16003C FDA UDI
- Primary DI / UDI-DI
- 00389154000075 FDA UDI
- 510(k) Number
- K113307 FDA UDI
- FDA Product Code
- LFR FDA UDIJJX FDA UDINBW FDA UDI
- GMDN Term
- Home-use/point-of-care blood glucose/blood pressure monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI862.1660 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
GL GoodLife Blood Glucose Test Strip AC (50ct in foil) by Hmd Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K113307 also covers:
- GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.) — Hmd Biomedical, LLC
- GL GoodLife AC-302 Blood Glucose Monitoring System, Economy type(CORP.) — Hmd Biomedical, LLC
- GL GoodLife AC11-Strip(foil) — Hmd Biomedical, LLC
- GL GoodLife Blood Glucose Test Strip(CORP.) — Hmd Biomedical, LLC
- GoodLife foil packed test strip — Hmd Biomedical, LLC
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
- Hmd Biomedical, LLC
Sources (1)
- FDA UDI 120225fd-044a-4df5-86dc-dce5d42d0ab3 38 fields · synced Jun 6, 2026