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Contour® Next Link

FDA UDI

Class I (US FDA UDI)

by Ascensia Diabetes Care Us Inc.

Identity

Trade Name
CONTOUR® NEXT LINK FDA UDI
Generic Name
Glucose monitoring system IVD, home-use FDA UDI
Device Name
Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR® NEXT LINK Blood Glucose Meter; 25 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; MICROLET® 2 Lancing Device; Alternative Site Endcap; Adjustable Endcap; 25 Lancets (provided sterile); Quick Reference Guide; Wall Charger; User Guide; USB Extension Cable; Logbook; Carrying Case. FDA UDI
Model / Reference
9624 FDA UDI
Description
Wireless Blood Glucose Monitoring System. 1 kit. This kit contains the following items: CONTOUR® NEXT LINK Blood Glucose Meter; 25 CONTOUR® NEXT Blood Glucose Test Strips; CONTOUR® NEXT Level 2 Control Solution; MICROLET® 2 Lancing Device; Alternative Site Endcap; Adjustable Endcap; 25 Lancets (provided sterile); Quick Reference Guide; Wall Charger; User Guide; USB Extension Cable; Logbook; Carrying Case. FDA UDI

Identifiers

Catalog Number
83623013 FDA UDI
Primary DI / UDI-DI
00301939624016 FDA UDI
510(k) Number
K110894 FDA UDI
K122370 FDA UDI
K160430 FDA UDI
FDA Product Code
JJX FDA UDI
LFR FDA UDI
NBW FDA UDI
GMDN Term
Glucose monitoring system IVD, home-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
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

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

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

Cleared under the same submission

K160430 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 38ea8e0a-e934-4979-8fe7-fffc221c6c31 38 fields · synced Jun 8, 2026