Duns Number:484942081
Device Description: FISSO Breathing Circuit Holder:This product is used to hold and position breathing circuit FISSO Breathing Circuit Holder:This product is used to hold and position breathing circuits. Consisting of: Universal circuit holder plate for various Ø 14mm until Ø 23.5mm and coaxial > Ø 30 mm.
Catalog Number
2628.10
Brand Name
FISSO
Version/Model Number
2628.10
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
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
e035af58-567a-46f8-976a-996401b20941
Public Version Date
October 27, 2021
Public Version Number
2
DI Record Publish Date
June 16, 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 |