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CONTOUR® NEXT ONE, CONTOUR® NEXT EZ, and CONTOUR® NEXT

FDA UDI

Class II (US FDA UDI)

by Ascensia Diabetes Care Us Inc.

Identity

Trade Name
CONTOUR® NEXT ONE, CONTOUR® NEXT EZ, and CONTOUR® NEXT FDA UDI
Generic Name
Glucose monitoring system IVD, home-use FDA UDI
Device Name
Mixed product shipper case containing 3 CONTOUR® NEXT ONE Blood Glucose Monitoring System kits (Primary DI Number 00301939763012), 3 CONTOUR® NEXT EZ Blood Glucose Monitoring System kits (Primary DI Number 00301939628014) and 12 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Primary DI Number 10301937308502). FDA UDI
Model / Reference
9647 FDA UDI
Description
Mixed product shipper case containing 3 CONTOUR® NEXT ONE Blood Glucose Monitoring System kits (Primary DI Number 00301939763012), 3 CONTOUR® NEXT EZ Blood Glucose Monitoring System kits (Primary DI Number 00301939628014) and 12 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Primary DI Number 10301937308502). FDA UDI

Identifiers

Catalog Number
85873989 FDA UDI
Primary DI / UDI-DI
40301939647518 FDA UDI
510(k) Number
K111268 FDA UDI
K121190 FDA UDI
K130265 FDA UDI
K160430 FDA UDI
K160682 FDA UDI
K162336 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
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

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

CONTOUR® NEXT ONE, CONTOUR® NEXT EZ, and CONTOUR® NEXT by Ascensia Diabetes Care Us Inc. — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K111268 also covers:

K121190 also covers:

K130265 also covers:

K160430 also covers:

K160682 also covers:

K162336 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 e7263558-ad0a-45b4-8bbe-814cc1616b33 38 fields · synced Jun 8, 2026