Duns Number:680255366
Device Description: This medical device is an Air Pump, and also named as Alternating Control Unit or Alternat This medical device is an Air Pump, and also named as Alternating Control Unit or Alternating-Pressure Pump, it is always used with an Air Mattress together, and combines into a Mattress System (Alternating Air Pressure Mattress), its function is controlling the Air Mattress to be inflated and deflated alternatively with a setting cycle time.
Catalog Number
-
Brand Name
Aeda
Version/Model Number
MT-A3-301
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)
Yes
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
c9a26395-87d8-4abb-a8c8-fa97f5352b41
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
July 31, 2017
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. | 12 |