Duns Number:134139174
Device Description: SWAN-GANZ CCOMBO THERMODILUTION CATHETER
Catalog Number
744F75
Brand Name
SWAN-GANZ CCOMBO
Version/Model Number
744F75
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)
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
K160084
Product Code
DQE
Product Code Name
CATHETER, OXIMETER, FIBEROPTIC
Public Device Record Key
4d5ce981-9961-4268-b65b-90669abead8c
Public Version Date
March 10, 2021
Public Version Number
5
DI Record Publish Date
September 03, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |