Duns Number:080935429
Device Description: Hovertech Hovermatt Lateral Transfer Mattress
Catalog Number
ST-HM34SPU-B
Brand Name
CARDINAL HEALTH
Version/Model Number
ST-HM34SPU-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)
Yes
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
25c225e8-703d-4ca2-80e8-ad28ea59fed5
Public Version Date
October 11, 2019
Public Version Number
1
DI Record Publish Date
October 03, 2019
Package DI Number
50885380168480
Quantity per Package
10
Contains DI Package
10885380168482
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 | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |