Vital Signs

Cardiac output in-line injectate probe for GE monitors, ICU Medical Thermoset, 2.4 m/8 ft

Registry build 21.09.26
1manufacturer
6catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DQE
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77

Record

Regulatory record for Vital Signs
Listed by Carefusion Finland 320 Oy
FDA product code DQE
Device type Catheter, Oximeter, Fiber-Optic
Device class Class 2
Regulation 21 CFR 870.1230
Record published 2016-09-14
Record revised 2024-05-21 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Storage Storage environment temperature -22 to 140 °F
Distribution end date 2022-03-31

Catalogue Numbers

Catalogue numbers for Vital Signs
Catalogue number Size Status
2025248-001 Withdrawn
9446-909 Withdrawn
2025248-002 Withdrawn
9446-913 Withdrawn
9446-911 Withdrawn
9446-910 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ICU Medical ICU Medical, Inc 65
Vital Signs™ AirLife Finland Oy 12
Swan-Ganz Edwards Lifesciences Technology Sarl 7
Edwards Oximetry Central Venous Catheter Edwards Lifesciences Technology Sarl 6
HemoSphere Edwards Lifesciences Technology Sarl 5
Swan-Ganz True Size Edwards Lifesciences Technology Sarl 3
HemoSphere Alta Edwards Lifesciences Technology Sarl 3
Flotrac Edwards Lifesciences Technology Sarl 3
Vigileo Edwards Lifesciences Technology Sarl 2
ForeSight IQ Edwards Lifesciences Technology Sarl 1
Pediasat Edwards Lifesciences Technology Sarl 1
Presep Edwards Lifesciences Technology Sarl 1

Showing 12 of 18. All products under Catheter, Oximeter, Fiber-Optic

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer