Duns Number:809699023
Device Description: BioFlo Midline with ENDEXO Technology (5F x 20cm, Dual Lumen) - Maximal Barrier Dual Fene BioFlo Midline with ENDEXO Technology (5F x 20cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
Catalog Number
-
Brand Name
BioFlo
Version/Model Number
46-029
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
K163452
Product Code
LJS
Product Code Name
Catheter, intravascular, therapeutic, long-term greater than 30 days
Public Device Record Key
5a3d9be2-f31d-46fb-9921-49c4cd1fa2f6
Public Version Date
May 06, 2021
Public Version Number
4
DI Record Publish Date
June 04, 2019
Package DI Number
H965460291
Quantity per Package
5
Contains DI Package
H965460290
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 |