Selfinject

FDA UDI

Class II (US FDA UDI)

by CHIRANA T.Injecta, a. s.

Identity

Trade Name: Selfinject FDA UDI
Generic Name: Insulin syringe/needle, basic FDA UDI
Device Name: 1ml U100 insulin syringe with integrated needle 30G x 1/2” (0,3 x 12,7mm) in blister packaging, for single use. FDA UDI
Model / Reference: U100 1ml 30G x 1/2” FDA UDI
Description: 1ml U100 insulin syringe with integrated needle 30G x 1/2” (0,3 x 12,7mm) in blister packaging, for single use. FDA UDI

Identifiers

Catalog Number: AP03-21-00 FDA UDI
Primary DI / UDI-DI: 08586015049675 FDA UDI
510(k) Number: K242434 FDA UDI
FDA Product Code: FMF FDA UDI
FMI FDA UDI
GMDN Term: Insulin syringe/needle, basic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
880.5570 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1 Milliliter FDA UDI
Needle Gauge — 30 Gauge FDA UDI

Category: Insulin syringe/needle, basic

Selfinject by CHIRANA T.Injecta, a. s. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct — ARISE MEDICAL LLC · Class II

Cleared under the same submission

K242434 also covers:

Selfinject — CHIRANA T.Injecta, a. s.

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: CHIRANA T.Injecta, a. s.

Sources (1)

FDA UDI d9fe1121-c449-4f6d-83f3-3fec3e9e5304 37 fields · synced May 30, 2026