Duns Number:008124539
Device Description: DynaRest Plus Bariatric Foam Mattress 80"x48"x6"
Catalog Number
-
Brand Name
Bariatric Plus Foam Mattress 48" x 80"
Version/Model Number
10432
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"
Yes
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
IKY
Product Code Name
Mattress, Flotation Therapy, Non-Powered
Public Device Record Key
a571007f-7a0c-49e8-8512-191e800e7229
Public Version Date
July 18, 2022
Public Version Number
2
DI Record Publish Date
April 22, 2021
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |