Portex

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Portex FDA UDI
Generic Name: Medication transfer needle, filtering FDA UDI
Model / Reference: 24-1356-64 FDA UDI

Identifiers

Primary DI / UDI-DI: 15019517071412 FDA UDI
510(k) Number: K172410 FDA UDI
FDA Product Code: BSN FDA UDI
MIA FDA UDI
BSP FDA UDI
CAZ FDA UDI
GMDN Term: Medication transfer needle, filtering FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5130 FDA UDI
868.5150 FDA UDI
868.5140 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: Medication transfer needle, filtering

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

Similar devices

Also classified as Medication transfer needle, filtering.

Dash 6 — Intervene Group Limited · Class II
Filter Needle — B. BRAUN MEDICAL INC. · Class I
Mix2Vial Transfer Device — WEST PHARMA. SERVICES IL, . LTD · Class II
Ceros — RHINO MEDICAL SUPPLY INC · Class I
Covidien — Cardinalhealth · Class II
Monoject — Cardinalhealth · Class I
RELI® — MYCO MEDICAL SUPPLIES INC. · Class I
BD Integra 18G 1 1/2IN Blunt Filter Needle — BECTON DICKINSON AND COMPANY · Class II

Cleared under the same submission

K172410 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 b102265b-1f07-4da1-bb72-470c2916f3d5 33 fields · synced Jun 1, 2026