Duns Number:132016168
Device Description: Alternating Pressure/Low Air Loss Overlay System
Catalog Number
-
Brand Name
LUMEX
Version/Model Number
14025
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
ae0f5a32-1777-4f0e-b60f-bf3cb5449b67
Public Version Date
July 25, 2019
Public Version Number
3
DI Record Publish Date
August 31, 2016
Package DI Number
M368140252
Quantity per Package
2
Contains DI Package
M368140251
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 202 |