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Portex

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
Portex FDA UDI
Generic Name
Breathing circuit bag, single-use FDA UDI
Model / Reference
225-3212-700 FDA UDI

Identifiers

Primary DI / UDI-DI
10351688429803 FDA UDI
FDA Product Code
CBN FDA UDI
GMDN Term
Breathing circuit bag, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5430 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Breathing circuit bag, single-use

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

Similar devices

Also classified as Breathing circuit bag, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI 445c7f52-2217-493c-899e-c7b3fdf78241 32 fields · synced May 31, 2026