Duns Number:100439103
Device Description: AirPal Disposable Transfer Pad, 28" W x 78" L, Long Handle
Catalog Number
-
Brand Name
AirPal Repositioning Sheet
Version/Model Number
RM-AP-028SPSLH
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
Yes
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
FMR
Product Code Name
Device, Transfer, Patient, Manual
Public Device Record Key
6976fcc0-fdd6-4030-ae86-22a1f7bab58f
Public Version Date
October 19, 2021
Public Version Number
2
DI Record Publish Date
February 24, 2021
Package DI Number
10816317023840
Quantity per Package
10
Contains DI Package
00816317023843
Package Discontinue Date
-
Package Status
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 | 68 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |