D-Care

FDA UDI

Class II (US FDA UDI)

by Hudson Scientific Llc

Identity

Trade Name: D-Care FDA UDI
Generic Name: Home-use blood glucose spot-check system FDA UDI
Device Name: DM2- kit contains one 60ct. bottle of Metformin 500mg and one 50ct. bottle Test Strips FDA UDI
Model / Reference: 50002A FDA UDI
Description: DM2- kit contains one 60ct. bottle of Metformin 500mg and one 50ct. bottle Test Strips FDA UDI

Identifiers

Primary DI / UDI-DI: 00370914006017 FDA UDI
510(k) Number: K132086 FDA UDI
FDA Product Code: NBW FDA UDI
JJX FDA UDI
CGA 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
862.1660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Home-use blood glucose spot-check system

D-Care by Hudson Scientific Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home-use blood glucose spot-check system.

AIMSTRIP PLUS, BLOOD GLUCOSE TEST STRIPS — GERMAINE LABORATORIES, INC. · Class II
AIMSTRIP PLUS BLOOD GLUCOSE METER, BOX KIT — GERMAINE LABORATORIES, INC. · Class II
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
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
VivaGuard Ino Blood Glucose Test Strips — ABOUND Diagnostics, Inc · Class II

Cleared under the same submission

K132086 also covers:

D-Care — HUDSON SCIENTIFIC LLC
D-Care — HUDSON SCIENTIFIC 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

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Manufacturer

Manufacturer: Hudson Scientific Llc

Sources (1)

FDA UDI 242eea32-ccb8-4722-bc43-2e3c3d7461d6 36 fields · synced Jun 8, 2026