Duns Number:135241342
Device Description: Pulsation, True Low Air Loss 10" High, 80"~85"~90" Variable Length Long Mattress, Standard Pulsation, True Low Air Loss 10" High, 80"~85"~90" Variable Length Long Mattress, Standard System
Catalog Number
K-3-VL-MS
Brand Name
K-3 AIRE-ZONE
Version/Model Number
K-3-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
IOQ
Product Code Name
Bed, Flotation Therapy, Powered
Public Device Record Key
acbdec3e-1128-4611-860d-6e126210170b
Public Version Date
August 21, 2020
Public Version Number
1
DI Record Publish Date
August 13, 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 |