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Abound®

FDA UDI

Class II (US FDA UDI)

by Ascensia Diabetes Care Us Inc.

Identity

Trade Name
ABOUND® FDA UDI
Generic Name
Blood lancing device tip FDA UDI
Device Name
Welcome kit - contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit (Primary DI Number 00301939763012), 1 carton of CONTOUR® NEXT ONE Blood Glucose Test Strips (Package DI Number 00301937312212), 100 MICROLET® lancets (provided sterile), recipe cards, activity cards, resistance bands (labeled latex free), relaxation mask. FDA UDI
Model / Reference
7770 FDA UDI
Description
Welcome kit - contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit (Primary DI Number 00301939763012), 1 carton of CONTOUR® NEXT ONE Blood Glucose Test Strips (Package DI Number 00301937312212), 100 MICROLET® lancets (provided sterile), recipe cards, activity cards, resistance bands (labeled latex free), relaxation mask. FDA UDI

Identifiers

Catalog Number
90005192 FDA UDI
Primary DI / UDI-DI
40301937770515 FDA UDI
FDA Product Code
FMK FDA UDI
LFR FDA UDI
NBW FDA UDI
GMDN Term
Blood lancing device tip FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4850 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

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

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 0c8a238d-b947-453f-ac89-8704bc6c881e 37 fields · synced Jun 8, 2026