Duns Number:132016168
Device Description: Clinical Plus Bariatric Alternating Pressure/Low Air Loss Mattress System
Catalog Number
-
Brand Name
SIMMONS Clinical Care
Version/Model Number
760000SB
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
2d69e2e8-3bd2-466d-a059-c9338a280ca6
Public Version Date
July 25, 2019
Public Version Number
3
DI Record Publish Date
August 31, 2016
Package DI Number
M368760000SB2
Quantity per Package
2
Contains DI Package
M368760000SB1
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 | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 202 |