Contour® Next One

FDA UDI

Class II (US FDA UDI)

by Ascensia Diabetes Care Us Inc.

Identity

Trade Name: CONTOUR® NEXT ONE 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. Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution. FDA UDI
Model / Reference: 9765 FDA UDI
Description: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution. FDA UDI

Identifiers

Catalog Number: 85602314 FDA UDI
Primary DI / UDI-DI: 00301939765016 FDA UDI
510(k) Number: K160682 FDA UDI
K191286 FDA UDI
K210687 FDA UDI
FDA Product Code: LFR FDA UDI
NBW FDA UDI
GMDN Term: Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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 One by Ascensia Diabetes Care Us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K160682 also covers:

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: Ascensia Diabetes Care Us Inc.

Sources (1)

FDA UDI a73419a4-5926-4492-aef9-889b6678f03d 37 fields · synced Jun 8, 2026