Duns Number:355804758
Device Description: Mattress - Alternating Pressure - Therakair Visio - Length 208 cm, Width 80 cm, Height 2 Mattress - Alternating Pressure - Therakair Visio - Length 208 cm, Width 80 cm, Height 20cm
Catalog Number
-
Brand Name
THERAKAIR VISIO
Version/Model Number
M6265529
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2022
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FNM
Product Code Name
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Public Device Record Key
830c56c2-042b-4bb6-84af-a19a0e6f0e96
Public Version Date
October 03, 2022
Public Version Number
3
DI Record Publish Date
September 29, 2016
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 | 420 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 840 |