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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 diabetes. This kit contains the following items: CONTOUR® Next Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case; CONTOUR® NEXT Control Solution; Warranty Card. FDA UDI
Model / Reference
9697 FDA UDI
Description
Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of diabetes. This kit contains the following items: CONTOUR® Next Blood Glucose Meter; 10 CONTOUR® NEXT Blood Glucose Test Strips; User Guide; Quick Reference Guide; Lancing Device; 10 Colored Lancets (provided sterile); Logbook; Carrying Case; CONTOUR® NEXT Control Solution; Warranty Card. FDA UDI

Identifiers

Catalog Number
84413500 FDA UDI
Primary DI / UDI-DI
00301939697010 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
Not 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

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K121190 also covers:

K160430 also covers:

K191286 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascensia Diabetes Care Us Inc.

Sources (1)

  • FDA UDI 23d2ecae-fbfd-4a0b-bb17-a5de41ff5af8 38 fields · synced Jun 8, 2026