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Contour® Next

FDA UDI

Class III (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 Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)). FDA UDI
Model / Reference
7283 FDA UDI
Description
Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)). FDA UDI

Identifiers

Catalog Number
84698032 FDA UDI
Primary DI / UDI-DI
00301937283352 FDA UDI
PMA Number
P150001 FDA UDI
P160017 FDA UDI
510(k) Number
K121190 FDA UDI
K160430 FDA UDI
K162336 FDA UDI
FDA Product Code
OZO FDA UDI
NBW FDA UDI
LFR FDA UDI
OZP FDA UDI
GMDN Term
Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
862.1345 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Cleared under the same submission

K121190 also covers:

K160430 also covers:

K162336 also covers:

P150001 also covers:

P160017 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 b1653fc7-fb56-4f31-b79e-5f24d1376209 38 fields · synced Jun 8, 2026