VivaGuard

FDA UDI

Class II (US FDA UDI)

by Able Diagnostics Inc

Identity

Trade Name: VivaGuard FDA UDI
Generic Name: Blood lancet, single-use FDA UDI
Device Name: VivaGuard Safety Lancets (100s) FDA UDI
Model / Reference: VGL02 FDA UDI
Description: VivaGuard Safety Lancets (100s) FDA UDI

Identifiers

Catalog Number: VGL02-382 FDA UDI
Primary DI / UDI-DI: 00853483008137 FDA UDI
FDA Product Code: FMK FDA UDI
GMDN Term: Blood lancet, 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Blood lancet, single-use

VivaGuard by Able 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: Able Diagnostics Inc

Sources (1)

FDA UDI 4d219bfe-3554-47fd-8f05-3d93659996aa 34 fields · synced Jun 1, 2026