Duns Number:135241342
Device Description: Rotation, with On-Demand Low Air Loss 10" High, 80"~85"~90" Variable Length Long Mattress, Rotation, with On-Demand Low Air Loss 10" High, 80"~85"~90" Variable Length Long Mattress, Standard System
Catalog Number
K-6oem-VL-MS
Brand Name
K-6oem AIRE-TURN
Version/Model Number
K-6oem-VL-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
IKZ
Product Code Name
Bed, Patient Rotation, Powered
Public Device Record Key
3e7a7e77-b193-4059-9c5a-157a2b5938f5
Public Version Date
August 24, 2020
Public Version Number
1
DI Record Publish Date
August 14, 2020
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 |