Duns Number:135241342
Device Description: Alternating Pressure, Auto Immersion, On-Demand Low Air Loss, Auto Variable Length, Mattre Alternating Pressure, Auto Immersion, On-Demand Low Air Loss, Auto Variable Length, Mattress System, 80"~85"~90"x 36"x 8".
Catalog Number
K-2-SM-AVL-MS-8
Brand Name
K-2SM SmartMatt
Version/Model Number
K-2-SM-AVL-MS-8
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
43335a17-479e-4eb4-b9b5-646e07ddc27d
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 2022
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1029 |