← Back to catalogue

ICU Medical

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
ICU Medical FDA UDI
Generic Name
Pulmonary artery balloon catheter, oximetric FDA UDI
Device Name
TriOx™ ScvO2 Central Venous Oximetry Catheter, Expanded Kit FDA UDI
Model / Reference
50467-01 FDA UDI
Description
TriOx™ ScvO2 Central Venous Oximetry Catheter, Expanded Kit FDA UDI

Identifiers

Catalog Number
504670401 FDA UDI
Primary DI / UDI-DI
00840619046620 FDA UDI
FDA Product Code
DQE FDA UDI
GMDN Term
Pulmonary artery balloon catheter, oximetric FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1230 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

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

No

FDA UDI

Category: Pulmonary artery balloon catheter, oximetric

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

Similar devices

Also classified as Pulmonary artery balloon catheter, oximetric.

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 285f2b9b-dfe0-4494-ae8b-80c01ac39b0b 35 fields · synced Jun 1, 2026