Jelco

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Jelco FDA UDI
Generic Name: Hypodermic needle, single-use FDA UDI
Model / Reference: 401910 FDA UDI

Identifiers

Primary DI / UDI-DI: 00351688069798 FDA UDI
510(k) Number: K071785 FDA UDI
FDA Product Code: FMI FDA UDI
GMDN Term: Hypodermic needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Yes

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: Hypodermic needle, single-use

Jelco by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Hypodermic needle, single-use.

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Yeso med — WUXI YUSHOU MEDICAL APPLIANCES CO., LTD. · Class II
EasyTouch — MHC Medical Products · Class II
STERiJECT TM — TSK LABORATORY, JAPAN · Class II
Comfort EZ Pro — S.D.I. USA, INC. · Class II

Cleared under the same submission

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: Icu Medical, Inc.

Sources (1)

FDA UDI ae3ae14e-2d01-4dc6-a976-eb66d26acc19 33 fields · synced May 30, 2026