Duns Number:079105071
Device Description: UniFuse Infusion System w/ Cooper Wire
Catalog Number
-
Brand Name
UniFuse
Version/Model Number
12401843
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"
-
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
K163356,K951509
Product Code
KRA
Product Code Name
Catheter, continuous flush
Public Device Record Key
2a6b743d-f36e-467e-911b-7ec505d093de
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
September 19, 2016
Package DI Number
H787124018435
Quantity per Package
1
Contains DI Package
H787124018430
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 203 |