Duns Number:831704841
Device Description: Uni-Flo™ Fenestrated Catheter – 2.5 inch (63.5 mm), 19 GA x 36 in (914mm)
Catalog Number
220489
Brand Name
Uni-Flo
Version/Model Number
220489
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
-
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
8350386f-46ad-413d-ac84-759bb4dd0be5
Public Version Date
February 07, 2019
Public Version Number
7
DI Record Publish Date
September 09, 2016
Package DI Number
20857595005415
Quantity per Package
10
Contains DI Package
00857595005411
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 70 |