Duns Number:100439103
Device Description: HoverMatt Lateral Transfer Mattress HM39SPU-LNK-B
Catalog Number
-
Brand Name
HoverMatt Lateral Transfer Mattress
Version/Model Number
RM-HM39SPU-LNK-B
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
24d0e0b9-db2d-473f-a7e1-77083538fb7c
Public Version Date
October 19, 2021
Public Version Number
3
DI Record Publish Date
June 27, 2019
Package DI Number
10816317023550
Quantity per Package
10
Contains DI Package
00816317023553
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 | 68 |
2 | A medical device with a moderate to high risk that requires special controls. | 95 |