Contour® Next

FDA UDI

Class I (US FDA UDI)

by Ascensia Diabetes Care Us Inc.

Identity

Trade Name: CONTOUR® NEXT FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. In this kit you will find: CONTOUR® NEXT Blood Glucose Meter; 20 CONTOUR® NEXT Blood Glucose Test Strips; User Guide and Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook and Carrying Case; Warranty Card. FDA UDI
Model / Reference: 7379 FDA UDI
Description: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. In this kit you will find: CONTOUR® NEXT Blood Glucose Meter; 20 CONTOUR® NEXT Blood Glucose Test Strips; User Guide and Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook and Carrying Case; Warranty Card. FDA UDI

Identifiers

Catalog Number: 81668523 FDA UDI
Primary DI / UDI-DI: 00301937379017 FDA UDI
510(k) Number: K121190 FDA UDI
K160430 FDA UDI
K191286 FDA UDI
FDA Product Code: JJX FDA UDI
LFR FDA UDI
NBW FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
862.1345 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

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose monitoring system IVD, home-use

Contour® Next by Ascensia Diabetes Care Us Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Glucose monitoring system IVD, home-use.

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ReliOn® Confirm/micro Blood Glucose Test Strips — Walmart Stores · Class II
LEADER — Cardinal Health 110, Inc. · Class II
CareSens N Voice Multi — i-SENS, Inc. · Class II
Oh'Care Lite — IJDREAM CORPORATION · Class I

Cleared under the same submission

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 I	Pending data

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Manufacturer

Manufacturer: Ascensia Diabetes Care Us Inc.

Sources (1)

FDA UDI 651f7dec-a5fd-453c-99b9-d8d3b4c02bc7 37 fields · synced Jun 8, 2026