Duns Number:135241342
Device Description: Alternating Pressure, On-Demand Low Air Loss, Auto Set, Pulse, Auto Expansion, Mattress Sy Alternating Pressure, On-Demand Low Air Loss, Auto Set, Pulse, Auto Expansion, Mattress System, 80"~85"~90" x 36"~42"~48" x 10".
Catalog Number
K-2-AX-MS
Brand Name
K-2 KARE-ZONE
Version/Model Number
K-2-AX-MS
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
be5dc4b1-14b9-4f39-97bd-69b4d24af223
Public Version Date
April 04, 2022
Public Version Number
1
DI Record Publish Date
March 25, 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 |