Duns Number:134139174
Device Description: SWAN-GANZ TRUE SIZE CATHETER DOUBLE LUMEN CATHETER
Catalog Number
111NX7P
Brand Name
Swan Ganz Catheter
Version/Model Number
111NX7P
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
e3c6a692-24de-48cc-914b-d4750f470589
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
September 17, 2020
Package DI Number
50690103198435
Quantity per Package
5
Contains DI Package
00690103198430
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 |