Duns Number:135241342
Device Description: Stratus Air B48, AP, On-Demand Low Air Loss, Mattress System 80" x 48" x 8", with Injectio Stratus Air B48, AP, On-Demand Low Air Loss, Mattress System 80" x 48" x 8", with Injection Molded Housing
Catalog Number
K-2oem-O-NM1-B48-8
Brand Name
K-2oem ALT-AIRE+
Version/Model Number
K-2oem-O-NM1-B48-8
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
bdb818c7-bb12-4adb-bd46-1328523d0365
Public Version Date
October 22, 2020
Public Version Number
1
DI Record Publish Date
October 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 |