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CURO Glucose Strips

FDA UDI

Class II (US FDA UDI)

by Kpi Healthcare, Inc.

Identity

Trade Name
CURO Glucose Strips FDA UDI
Generic Name
Ambulatory insulin infusion pump/interstitial glucose monitoring system FDA UDI
Device Name
CURO Glucose Strips for G6 and G6s FDA UDI
Model / Reference
CURO Glucose Strips FDA UDI
Description
CURO Glucose Strips for G6 and G6s FDA UDI

Identifiers

Primary DI / UDI-DI
00860394001294 FDA UDI
FDA Product Code
LFR FDA UDI
JJX FDA UDI
NBW FDA UDI
GMDN Term
Ambulatory insulin infusion pump/interstitial glucose monitoring 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Glucose monitoring system IVD, home-useGlucose monitoring system IVD, point-of-careBlood glucose/blood pressure monitoring system, home-useGlucose analyser IVD, home-use

CURO Glucose Strips by Kpi Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose analyser IVD, laboratory, manual.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kpi Healthcare, Inc.

Sources (1)

  • FDA UDI c097bc80-3330-4a22-a984-d5272995b511 33 fields · synced Jun 8, 2026