Duns Number:078470558
Catalog Number
2780-800-000
Brand Name
SofCare
Version/Model Number
2780-800-000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 23, 2021
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
d9ea2f14-5c56-44d4-b902-b264c92d5b08
Public Version Date
September 14, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
57613327278571
Quantity per Package
6
Contains DI Package
07613327278576
Package Discontinue Date
February 23, 2021
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 | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |