LIVE TULA LT-THIN Lancets(100PCS/BOX)

FDA UDI

Class II (US FDA UDI)

by Tula Health, Inc.

Identity

Trade Name: LIVE TULA LT-THIN Lancets(100PCS/BOX) FDA UDI
Generic Name: Blood lancing device tip FDA UDI
Model / Reference: TD-5084 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850065253275 FDA UDI
510(k) Number: K221419 FDA UDI
FDA Product Code: FMK 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

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blood lancing device tip

LIVE TULA LT-THIN Lancets(100PCS/BOX) by Tula Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K221419 also covers:

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: Tula Health, Inc.

Sources (1)

FDA UDI 257387de-9bfc-414d-9bce-5fa6ef5672c9 33 fields · synced Jun 8, 2026