Duns Number:831375089
Device Description: ReusableINTENDED USE/ CONTRAINDICATIONSPrernierPro'" Air Transfer Mats are indicated for p
Catalog Number
3722
Brand Name
PremierPro Air Transfer Mats
Version/Model Number
3722
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
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
FRZ
Product Code Name
Device, Patient Transfer, Powered
Public Device Record Key
ebd24981-f616-47f5-a883-209312a5f894
Public Version Date
February 08, 2019
Public Version Number
2
DI Record Publish Date
April 10, 2018
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 | 486 |
2 | A medical device with a moderate to high risk that requires special controls. | 177 |
U | Unclassified | 1 |