Duns Number:134139174
Device Description: Swan-Ganz monitoring catheter double lumen
Catalog Number
123NX6P
Brand Name
Swan-Ganz Catheter
Version/Model Number
123NX6P
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
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
K193466,K193466
Product Code
DQE
Product Code Name
Catheter, Oximeter, Fiber-Optic
Public Device Record Key
4dcc0cf4-81c8-4de8-993b-c6aa377275a6
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
September 18, 2020
Package DI Number
50690103198459
Quantity per Package
5
Contains DI Package
00690103198454
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SHIPPER
| 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 |