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GL GoodLife Blood Glucose Test Strip

FDA UDI

Class II (US FDA UDI)

by Hmd Biomedical, LLC

Identity

Trade Name
GL GoodLife Blood Glucose Test Strip FDA UDI
Generic Name
Glucose monitoring system IVD, home-use FDA UDI
Device Name
GL GoodLife Blood Glucose Test Strip(AC-302) FDA UDI
Model / Reference
AC-11 AC302 (vial) FDA UDI
Description
GL GoodLife Blood Glucose Test Strip(AC-302) FDA UDI

Identifiers

Catalog Number
3S-01-16003E FDA UDI
Primary DI / UDI-DI
00389154000594 FDA UDI
510(k) Number
K113307 FDA UDI
FDA Product Code
LFR FDA UDI
NBW FDA UDI
GMDN Term
Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 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

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

GL GoodLife Blood Glucose Test Strip by Hmd Biomedical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K113307 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hmd Biomedical, LLC

Sources (1)

  • FDA UDI c42b7dcf-89e2-4592-baba-49c88b25536d 36 fields · synced Jun 6, 2026