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: Control Solution - Level 1. 1 x 2.5 mL. FDA UDI
Model / Reference: 7315 FDA UDI
Description: Control Solution - Level 1. 1 x 2.5 mL. FDA UDI

Identifiers

Catalog Number: 83624826 FDA UDI
Primary DI / UDI-DI: 10301937315012 FDA UDI
510(k) Number: K121190 FDA UDI
K151742 FDA UDI
K160430 FDA UDI
K160682 FDA UDI
K162336 FDA UDI
K191286 FDA UDI
K193407 FDA UDI
K210687 FDA UDI
K223293 FDA UDI
K241787 FDA UDI
FDA Product Code: JJX 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
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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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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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

K151742 also covers:

CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.

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 I	Pending data

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Manufacturer

Manufacturer: Ascensia Diabetes Care Us Inc.

Sources (1)

FDA UDI 1b0add37-248b-4793-b13c-160612f45feb 37 fields · synced Jun 8, 2026