Duns Number:656413127
Device Description: Serene Bariatric with 8"+2" Mattress
Catalog Number
-
Brand Name
APEX
Version/Model Number
Serene Bariatric with 8"+2" Mattress
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)
-
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
10b1b5ca-2a6b-4b43-8fdf-b08642123d26
Public Version Date
August 06, 2018
Public Version Number
1
DI Record Publish Date
July 04, 2018
Package DI Number
14713025004368
Quantity per Package
2
Contains DI Package
04713025004361
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 55 |