Duns Number:484942081
Device Description: FISSO Breathing Circuit Holder Light: Anaesthetic tube holder.This product is used to hold FISSO Breathing Circuit Holder Light: Anaesthetic tube holder.This product is used to hold and position breathing circuits. Consisting of: Universal circuit holder plate for various Ø 14.5 - 23.5 mm and coaxial > Ø 30 mm.
Catalog Number
3628.12
Brand Name
FISSO
Version/Model Number
3628.12
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
c2cb2bcc-d845-4cdc-a250-cdf2f24593d3
Public Version Date
October 27, 2021
Public Version Number
4
DI Record Publish Date
June 30, 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 | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |