Duns Number:658863238
Device Description: TheraFlo 9 M-set 90 x 200cm WDTX Carilex
Catalog Number
-
Brand Name
NA
Version/Model Number
S2001-2670
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 15, 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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IOQ
Product Code Name
Bed, Flotation Therapy, Powered
Public Device Record Key
c378d779-bb08-4e93-bf9b-8c0be1611fea
Public Version Date
August 15, 2022
Public Version Number
2
DI Record Publish Date
July 22, 2022
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 | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 144 |