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Pro Comfort Blood Glucose Monitor Kit

FDA UDI

Class II (US FDA UDI)

by Care Living Diagnostics Inc

Identity

Trade Name
Pro Comfort Blood Glucose Monitor Kit FDA UDI
Generic Name
Glucose monitoring system IVD, home-use FDA UDI
Device Name
BLOOD GLUCOSE MONITOR KIT BGM107 Meter BGM107 100 x Test Strips Lancing Device 100 x Lancets CR2032 Carrying Bag Instruction For Use (Read before use) Quick Start Guide FDA UDI
Model / Reference
BGM107 FDA UDI
Description
BLOOD GLUCOSE MONITOR KIT BGM107 Meter BGM107 100 x Test Strips Lancing Device 100 x Lancets CR2032 Carrying Bag Instruction For Use (Read before use) Quick Start Guide FDA UDI

Identifiers

Catalog Number
19871-5270-30 FDA UDI
Primary DI / UDI-DI
00198715270303 FDA UDI
510(k) Number
K052208 FDA UDI
FDA Product Code
CGA 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

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

Pro Comfort Blood Glucose Monitor Kit by Care Living Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K052208 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Care Living Diagnostics Inc

Sources (1)

  • FDA UDI 1c931e2d-1bff-499d-98ec-78a7c1ba5c76 36 fields · synced Jun 8, 2026