Duns Number:407157098
Device Description: Medisize HME Trach with safety valve
Catalog Number
-
Brand Name
Medisize®
Version/Model Number
303 720 000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 12, 2020
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
BYD
Product Code Name
Condenser, Heat And Moisture (Artificial Nose)
Public Device Record Key
5f5ea27e-520e-45e9-a28b-72fa8bb606ce
Public Version Date
May 14, 2020
Public Version Number
3
DI Record Publish Date
October 07, 2016
Package DI Number
18717146000182
Quantity per Package
50
Contains DI Package
08717146000185
Package Discontinue Date
May 12, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |