Duns Number:080593067
Device Description: DISPOSABLE CO-AXIAL ANAESTHESIA BREATHING CIRCUIT, T PIECE CONNECTOR, ADULT 30MM, 60", 2 L DISPOSABLE CO-AXIAL ANAESTHESIA BREATHING CIRCUIT, T PIECE CONNECTOR, ADULT 30MM, 60", 2 L LATEX FREE RESERVOIR BAG
Catalog Number
M409
Brand Name
MEDADV
Version/Model Number
M409
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"
Yes
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
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
6d97ed70-05e2-4f89-83e4-2ac037fcdf73
Public Version Date
May 11, 2018
Public Version Number
1
DI Record Publish Date
April 10, 2018
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 40 |