Duns Number:134139174
Device Description: SWAN-GANZ TRUE SIZE THERMODULTION CATHETER, 5F
Catalog Number
TS105NX5
Brand Name
SWAN-GANZ TRUE SIZE
Version/Model Number
TS105NX5
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
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
Product Code
DQE
Product Code Name
Catheter, Oximeter, Fiber-Optic
Public Device Record Key
3cf6706a-fd48-421b-9cde-318827e0b563
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
September 17, 2020
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 |