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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
Blood Glucose Test Strips (50 count) FDA UDI
Model / Reference
50003A FDA UDI
Description
Blood Glucose Test Strips (50 count) FDA UDI

Identifiers

Primary DI / UDI-DI
00370914003054 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

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

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.

Cleared under the same submission

K132086 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hudson Scientific Llc

Sources (1)

  • FDA UDI b93e5ed2-0a03-4fa5-b083-cfbaadec1f55 36 fields · synced May 31, 2026