Duns Number:314101143
Device Description: Cardiac Output Parameter Module for use with IntelliVue Patient Monitors. The Cardiac Outp Cardiac Output Parameter Module for use with IntelliVue Patient Monitors. The Cardiac Output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters using a technique called thermodilution. Supports either preloaded syringes or flow-through (CO-Set) technique.
Catalog Number
862279
Brand Name
PHILIPS IntelliVue Cardiac Output Parameter Module
Version/Model Number
Cardiac Output Parameter Module
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRT
Product Code Name
MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
Public Device Record Key
8f2397da-3f31-4be9-b28c-b90c6faecb79
Public Version Date
August 15, 2022
Public Version Number
6
DI Record Publish Date
November 02, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 209 |