Duns Number:484942081
Device Description: Respiration ArmFISSO Respiration Arm, is used to hold and position breathing circuits. Con Respiration ArmFISSO Respiration Arm, is used to hold and position breathing circuits. Consisting of: Twin Tube Holder / Swinging Head with fine adjustment / Fisso articulated Arm 900 mm / Column 100 mm.
Catalog Number
-
Brand Name
FISSO
Version/Model Number
3690.31-1786
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
-
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
ffa5fbb6-af5a-4e03-931a-9e6cad34e405
Public Version Date
October 28, 2021
Public Version Number
3
DI Record Publish Date
June 17, 2021
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 | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |