Jelco

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Jelco FDA UDI
Generic Name: Peripheral vascular catheter FDA UDI
Model / Reference: 328300 FDA UDI

Identifiers

Primary DI / UDI-DI: 10351688081971 FDA UDI
510(k) Number: K160235 FDA UDI
FDA Product Code: FOZ FDA UDI
GMDN Term: Peripheral vascular catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5200 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: Peripheral vascular catheter

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

Similar devices

Also classified as Peripheral vascular catheter.

Arterial Line Kit — Argon Medical Devices, Inc. · Class I
DELTAVEN — DELTA MED SPA · Class II
EXEL Safelet Catheter — Exel International · Class II
DELTAVEN — DELTA MED SPA · Class II
EXEL Safelet Catheter — Exel International · Class II
POWERWAND — Access Scientific, Inc. · Class II
ARROW — TELEFLEX INCORPORATED · Class II
DELTAVEN — DELTA MED SPA · Class II

Cleared under the same submission

K160235 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: Icu Medical, Inc.

Sources (1)

FDA UDI d035751d-aada-4b0d-853c-cd17c28d4c3c 33 fields · synced May 31, 2026