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 - 50 Test Strips. FDA UDI
Model / Reference: 7309 FDA UDI
Description: Blood Glucose Test Strips - 50 Test Strips. FDA UDI

Identifiers

Catalog Number: 83623080 FDA UDI
Primary DI / UDI-DI: 10301937309509 FDA UDI
PMA Number: P150001 FDA UDI
P160017 FDA UDI
510(k) Number: K121190 FDA UDI
K160430 FDA UDI
K162336 FDA UDI
K191286 FDA UDI
K193407 FDA UDI
K210687 FDA UDI
K223293 FDA UDI
K241787 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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 III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Glucose monitoring system IVD, home-use.

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TRUE METRIX GO — TRIVIDIA HEALTH, INC. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
ReliOn® Confirm/micro Blood Glucose Test Strips — Walmart Stores · Class II
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

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 III	Pending data

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Manufacturer

Manufacturer: Ascensia Diabetes Care Us Inc.

Sources (1)

FDA UDI 51ba452e-e4f7-4f2a-834f-3b1080f20d56 37 fields · synced Jun 8, 2026