← Back to catalogue

Portex

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
Portex FDA UDI
Generic Name
Tracheobronchial suction/insufflation catheter, single-lumen FDA UDI
Model / Reference
Z215-14 FDA UDI

Identifiers

Primary DI / UDI-DI
15019315046933 FDA UDI
FDA Product Code
CAF FDA UDI
BSY FDA UDI
GMDN Term
Tracheobronchial suction/insufflation catheter, single-lumen FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5630 FDA UDI
868.6810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tracheobronchial suction/insufflation catheter, single-lumen

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

Similar devices

Also classified as Tracheobronchial suction/insufflation catheter, single-lumen.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI dd6d2d10-e873-44c4-a645-cdf769c63f92 32 fields · synced Jun 8, 2026