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Contour® Diabetes App

FDA UDI

Class II (US FDA UDI)

by Ascensia Diabetes Care Us Inc.

Identity

Trade Name
CONTOUR® DIABETES APP FDA UDI
Generic Name
Self-care monitoring/reporting software FDA UDI
Device Name
Diabetes Management Software FDA UDI
Model / Reference
3536 FDA UDI
Description
Diabetes Management Software FDA UDI

Identifiers

Catalog Number
85498770 FDA UDI
Primary DI / UDI-DI
00301933536018 FDA UDI
510(k) Number
K193407 FDA UDI
K210687 FDA UDI
K223293 FDA UDI
K231679 FDA UDI
K241787 FDA UDI
FDA Product Code
NBW FDA UDI
GMDN Term
Self-care monitoring/reporting software 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

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Self-care monitoring/reporting software

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

Similar devices

Also classified as Self-care monitoring/reporting software.

Cleared under the same submission

K193407 also covers:

K210687 also covers:

K223293 also covers:

K231679 also covers:

K241787 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 3f6304eb-00d1-4698-af15-93b39ae9276c 36 fields · synced Jun 8, 2026