Duns Number:008124539
Device Description: Bubble Air Mattress Padfor item 10440, BeigePart of Alternating Pressure Pump and Pad Syst Bubble Air Mattress Padfor item 10440, BeigePart of Alternating Pressure Pump and Pad System
Catalog Number
-
Brand Name
Bubble Air Mattress Pad
Version/Model Number
10470
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
8ead77f1-4057-48c9-b779-ec79618849f4
Public Version Date
January 25, 2021
Public Version Number
1
DI Record Publish Date
January 15, 2021
Package DI Number
00616784047041
Quantity per Package
10
Contains DI Package
00616784047010
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |