Duns Number:246848147
Device Description: Flusso By-Pass Adapter
Catalog Number
420-1978S
Brand Name
Flusso™
Version/Model Number
420-1978S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 23, 2021
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
BZO
Product Code Name
SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
Public Device Record Key
d129997e-a7ee-4695-8fd0-8c327b7cc189
Public Version Date
May 26, 2022
Public Version Number
2
DI Record Publish Date
December 18, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 91 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |
| 3 | A medical device with high risk that requires premarket approval | 2 |