TRUEplus

FDA UDI

Class II (US FDA UDI)

by Trividia Health, Inc.

Identity

Trade Name: TRUEplus FDA UDI
Generic Name: Blood lancing device tip FDA UDI
Device Name: TRUEplus Sterile Lancets FDA UDI
Model / Reference: TRUEplus Sterile Lancets FDA UDI
Description: TRUEplus Sterile Lancets FDA UDI

Identifiers

Catalog Number: 743533 FDA UDI
Primary DI / UDI-DI: 00021292004484 FDA UDI
FDA Product Code: QRK FDA UDI
GMDN Term: Blood lancing device tip 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

Yes

FDA UDI

Convenience Kit

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 33 Gauge FDA UDI

Category: Blood lancing device tip

TRUEplus by Trividia Health, 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: Trividia Health, Inc.

Sources (1)

FDA UDI ebf9e4d8-1172-4691-91ea-ef17e2e3cbc5 36 fields · synced Jun 8, 2026