Duns Number:355804758
Device Description: Bath System - Freedom Bath, LA, Stillbath,
Catalog Number
-
Brand Name
Freedom Bath
Version/Model Number
AF21104-US
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"
-
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
ILJ
Product Code Name
Bath, hydro-massage
Public Device Record Key
98cea05c-6970-4d8e-b837-3995bd4bc115
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
October 26, 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 |