Duns Number:119253177
Device Description: The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution for access-c
Catalog Number
HERO 1003
Brand Name
HeRO® Graft Accessory Component Kit
Version/Model Number
HERO 1003
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 22, 2016
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DSY
Product Code Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Public Device Record Key
0348aa70-454f-4096-b241-19dac357573f
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
September 23, 2015
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 2 |