Duns Number:809699023
Device Description: BioFlo Midline with ENDEXO Technology Maximal Barrier Nursing Kit
Catalog Number
-
Brand Name
BioFlo
Version/Model Number
46490
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
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
17117ba4-64cb-4ca3-a0ce-6cd4523fa58e
Public Version Date
June 28, 2021
Public Version Number
6
DI Record Publish Date
September 20, 2016
Package DI Number
H965464901
Quantity per Package
5
Contains DI Package
H965464900
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 | 71 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1641 |