Duns Number:140727624
Device Description: Thermodilution Catheter 7.5F - 5 Lumen
Catalog Number
497520
Brand Name
Thermodilution Catheter
Version/Model Number
497520
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 02, 2017
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
DQO
Product Code Name
Catheter, Intravascular, Diagnostic
Public Device Record Key
9b7887d1-8455-4b61-8283-33a9e1d18449
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
20886333214666
Quantity per Package
5
Contains DI Package
00886333214662
Package Discontinue Date
November 02, 2017
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1205 |