Duns Number:680255366
Device Description: This medical device is an Air Mattress, it is consist of a series of air cells which is us This medical device is an Air Mattress, it is consist of a series of air cells which is used to support the patient when inflated, it is always used with an Air Pump, which is used to control the Air Mattress Cells (air cells) to be inflated and deflated alternatively with a setting cycle time, and keep the Air Cells in a setting pressure value.
Catalog Number
-
Brand Name
Aeda
Version/Model Number
3M01M060023
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
6f724d49-1f6c-4ddd-a5c9-343dedfad63c
Public Version Date
March 29, 2018
Public Version Number
2
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 |