Contour® Plus Blue

FDA UDI

Class II (US FDA UDI)

by Ascensia Diabetes Care Us Inc.

Identity

Trade Name: CONTOUR® PLUS BLUE FDA UDI
Generic Name: Glucose monitoring system IVD, home-use FDA UDI
Device Name: "For self - testing, monitoring, and management of blood glucose. Kit contains: -Contour Plus Blue blood glucose meter (Product of Indonesia) -10 Contour Plus blood glucose test strips (Product of Japan) -Microlet Next lancing device (Product of Poland) -10 Microlet lancets (Product of Poland) -User Guide -Quick Reference Guide -Carrying Case (Product of China)" FDA UDI
Model / Reference: 7035 FDA UDI
Description: "For self - testing, monitoring, and management of blood glucose. Kit contains: -Contour Plus Blue blood glucose meter (Product of Indonesia) -10 Contour Plus blood glucose test strips (Product of Japan) -Microlet Next lancing device (Product of Poland) -10 Microlet lancets (Product of Poland) -User Guide -Quick Reference Guide -Carrying Case (Product of China)" FDA UDI

Identifiers

Catalog Number: 90006207 FDA UDI
Primary DI / UDI-DI: 00301937035029 FDA UDI
510(k) Number: K231679 FDA UDI
K241787 FDA UDI
FDA Product Code: 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Glucose monitoring system IVD, home-use

Contour® Plus Blue by Ascensia Diabetes Care Us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K231679 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 II	Pending data

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Manufacturer

Manufacturer: Ascensia Diabetes Care Us Inc.

Sources (1)

FDA UDI 6b3d17b0-2704-4c4b-9368-c55eb6ad6661 37 fields · synced Jun 8, 2026