Duns Number:743982183
Device Description: A battery-powered device designed to be used by single trained operator to transport a hos A battery-powered device designed to be used by single trained operator to transport a hospital bed with steerable wheels with or without an occupant in a controlled manner within a hospital or associated environment. It typically consists of a chassis, batteries, an operator handle with operating panel, a bed gripping claw, electric motors that power the drive wheels, a remote control for operation/steering, brakes, and an emergency stop button. The device is attached (locked) to one end of the bed and pushes the bed, or pulls the bed after it. It is compatible for transport in lifts and for long and short internal transports.
Catalog Number
STM450
Brand Name
Staminalift
Version/Model Number
TS5000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
FNL
Product Code Name
Bed, Ac-Powered Adjustable Hospital
Public Device Record Key
8567fc74-b937-4c3f-87ff-d8fff35ebc1c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |