Portex

FDA UDI

Class I (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Portex FDA UDI
Generic Name: Anaesthesia breathing circuit, single-use FDA UDI
Model / Reference: C45101707-NL FDA UDI

Identifiers

Primary DI / UDI-DI: 15019315096273 FDA UDI
FDA Product Code: BTC FDA UDI
CAH FDA UDI
CAI FDA UDI
GMDN Term: Anaesthesia breathing circuit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5320 FDA UDI
868.5260 FDA UDI
868.5240 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

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: Anaesthesia breathing circuit, single-use

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

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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 I	Pending data

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Manufacturer

Manufacturer: Icu Medical, Inc.

Sources (1)

FDA UDI 49c2e8f6-2140-472f-9387-cc02af75be13 32 fields · synced Jun 1, 2026