Portex

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Portex FDA UDI
Generic Name: Pulmonary resuscitator, manual, single-use FDA UDI
Model / Reference: 008330 FDA UDI

Identifiers

Primary DI / UDI-DI: 10351688420503 FDA UDI
510(k) Number: K970785 FDA UDI
FDA Product Code: NHK FDA UDI
GMDN Term: Pulmonary resuscitator, manual, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5905 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: Pulmonary resuscitator, manual, single-use

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

Similar devices

Also classified as Pulmonary resuscitator, manual, single-use.

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HUDSON RCI — TELEFLEX INCORPORATED · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
VT Sure — Pulmodyne Inc. · Class II
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
Ventlab — Ventlab Corp. · Class I
Ventlab — Ventlab Corp. · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II

Cleared under the same submission

K970785 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 e47b1213-2bf8-4795-a2a3-6dea4265385b 33 fields · synced May 30, 2026