Duns Number:044611812
Device Description: PowerHohn Catheter for Central Venous Placement 5F Maximal Barrier Tray with Microintroduc PowerHohn Catheter for Central Venous Placement 5F Maximal Barrier Tray with Microintroducer (Single-Lumen) (50cm Nitinol Guidewire)
Catalog Number
AVA31851
Brand Name
PowerHohn Catheter for Central Venous Placement
Version/Model Number
AVA31851
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
09c2100e-937a-4230-896a-5b30deaf88a9
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2015
Package DI Number
10801741036818
Quantity per Package
3
Contains DI Package
00801741036811
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3348 |
| U | Unclassified | 8 |