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CONTOUR® NEXT EZ, CONTOUR® NEXT GEN and CONTOUR® NEXT

FDA UDI

Class II (US FDA UDI)

by Ascensia Diabetes Care Us Inc.

Identity

Trade Name
CONTOUR® NEXT EZ, CONTOUR® NEXT GEN 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 EZ Blood Glucose Monitoring System kits (Primary DI Number 00301939628014), 3 CONTOUR® NEXT Gen Blood Glucose Monitoring System kits (Primary DI Number 00301939658011) and 12 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Primary DI Number 10301937308502). FDA UDI
Model / Reference
9660 FDA UDI
Description
Mixed product shipper case containing 3 CONTOUR® NEXT EZ Blood Glucose Monitoring System kits (Primary DI Number 00301939628014), 3 CONTOUR® NEXT Gen Blood Glucose Monitoring System kits (Primary DI Number 00301939658011) and 12 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Primary DI Number 10301937308502). FDA UDI

Identifiers

Catalog Number
90004888 FDA UDI
Primary DI / UDI-DI
40301939660517 FDA UDI
FDA Product Code
NBW FDA UDI
LFR 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

No

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

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 8ee82b00-3497-4978-a71b-e29da62873f6 37 fields · synced Jun 8, 2026