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Curo L5

FDA UDI

Class I (US FDA UDI)

by Kpi Healthcare, Inc.

Identity

Trade Name
Curo L5 FDA UDI
Generic Name
Ambulatory insulin infusion pump/interstitial glucose monitoring system FDA UDI
Device Name
CURO L5 Glucose Strip FDA UDI
Model / Reference
Curo L5 FDA UDI
Description
CURO L5 Glucose Strip FDA UDI

Identifiers

Primary DI / UDI-DI
00850006113064 FDA UDI
510(k) Number
K130295 FDA UDI
FDA Product Code
LBR FDA UDI
JJX FDA UDI
JGY FDA UDI
CHH FDA UDI
CGA FDA UDI
NBW FDA UDI
GMDN Term
Ambulatory insulin infusion pump/interstitial glucose monitoring system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1475 FDA UDI
862.1660 FDA UDI
862.1705 FDA UDI
862.1175 FDA UDI
862.1345 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 L5 by Kpi Healthcare, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple physiological parameter spot-check system analyser.

Cleared under the same submission

K130295 also covers:

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 df209cfc-e124-4165-a579-2e5c644899fb 34 fields · synced May 30, 2026