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GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- GL GoodLife Blood Glucose Test Strip AC (50 Strips&lancets in foil) FDA UDI
- Generic Name
- Glucose IVD, kit, electrometry FDA UDI
- Device Name
- GL GoodLife Blood Glucose Test Strip(Foil) FDA UDI
- Model / Reference
- 3L-10-16003A FDA UDI
- Description
- GL GoodLife Blood Glucose Test Strip(Foil) FDA UDI
Identifiers
- Catalog Number
- 3L-10-16003A FDA UDI
- Primary DI / UDI-DI
- 00389154000204 FDA UDI
- 510(k) Number
- K113307 FDA UDI
- FDA Product Code
- LFR FDA UDIJJX FDA UDINBW FDA UDI
- GMDN Term
- Glucose IVD, kit, electrometry 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 (50 Strips&lancets in foil) by Hmd Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID
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 06b04728-c9d6-4981-bc73-5f5a4fc2578c 38 fields · synced Jun 1, 2026