Duns Number:134139174
Device Description: SWAN-GANZ HI-SHORE TRUE SIZE THERMODILUTION CATHETER
Catalog Number
141F7
Brand Name
SWAN-GANZ HI-SHORE TRUE SIZE
Version/Model Number
141F7
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,K160084
Product Code
DQE
Product Code Name
CATHETER, OXIMETER, FIBEROPTIC
Public Device Record Key
88f69ba1-c932-4dac-a089-b9c13615d378
Public Version Date
March 10, 2021
Public Version Number
5
DI Record Publish Date
September 03, 2016
Package DI Number
50690103000509
Quantity per Package
5
Contains DI Package
00690103000504
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 |