Duns Number:054326178
Device Description: TrendeMATS Mobile Air Transfer System for Trendelenburg Position
Catalog Number
700-093
Brand Name
Prevalon
Version/Model Number
700-093
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 07, 2021
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
Yes
For Single-Use
Yes
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
CCX
Product Code Name
SUPPORT, PATIENT POSITION
Public Device Record Key
ae0520ce-b860-49a7-a2de-693385d2669b
Public Version Date
July 26, 2022
Public Version Number
2
DI Record Publish Date
November 12, 2018
Package DI Number
50618029980019
Quantity per Package
5
Contains DI Package
00618029980014
Package Discontinue Date
October 07, 2021
Package Status
Not in Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 64 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |