Duns Number:407157098
Device Description: Medisize Gold Standard
Catalog Number
-
Brand Name
Medisize®
Version/Model Number
356 005 010B
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
BTT
Product Code Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Public Device Record Key
ae83c506-dd68-4c63-a0f2-106966146c70
Public Version Date
May 14, 2020
Public Version Number
3
DI Record Publish Date
October 07, 2016
Package DI Number
28717146000417
Quantity per Package
4
Contains DI Package
18717146000410
Package Discontinue Date
May 12, 2020
Package Status
Not in Commercial Distribution
Package Type
Case
| 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 |