Duns Number:958807575
Device Description: MEDTECH AIR MAX COMPLETE SYSTEM W/MEDTECH MAX PUMP AND SELECT PROTECT
Catalog Number
-
Brand Name
SelectAir Max
Version/Model Number
MDT24MEDMXRE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 12, 2016
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
8939f771-f371-4273-9c50-84a0150b53bc
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 05, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 91 |