Portex

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Portex FDA UDI
Generic Name: Airway pressure monitor, non-powered FDA UDI
Model / Reference: 008201 FDA UDI

Identifiers

Primary DI / UDI-DI: 10351688426352 FDA UDI
510(k) Number: K961318 FDA UDI
FDA Product Code: CAP FDA UDI
GMDN Term: Airway pressure monitor, non-powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2600 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

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: Airway pressure monitor, non-powered

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

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Cleared under the same submission

K961318 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 054134b9-a805-4094-9ca6-4293bb8d885c 33 fields · synced May 30, 2026