VivaGuard Lancing Device

FDA UDI

Class II (US FDA UDI)

by ABOUND Diagnostics, Inc

Identity

Trade Name: VivaGuard Lancing Device FDA UDI
Generic Name: Manual blood lancing device, single-use FDA UDI
Device Name: VivaGuard Lancing Device FDA UDI
Model / Reference: VGD01-381 FDA UDI
Description: VivaGuard Lancing Device FDA UDI

Identifiers

Catalog Number: VGD01-381 FDA UDI
Primary DI / UDI-DI: 00840423500134 FDA UDI
FDA Product Code: QRL FDA UDI
QRK FDA UDI
FMK FDA UDI
GMDN Term: Manual blood lancing device, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4850 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Manual blood lancing device, single-use

VivaGuard Lancing Device by ABOUND Diagnostics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: ABOUND Diagnostics, Inc

Sources (1)

FDA UDI d718a5cf-929d-4a76-bab3-5b7ca2740943 35 fields · synced Jun 8, 2026