AccessGUDID - DEVICE: Staminalift (B232TS50000)

GUDID

Device Identifier (DI) Information

Brand Name: Staminalift
Version or Model: TS5000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STM450
Company Name: STAMINALIFT INTERNATIONAL LIMITED

Primary DI Number: B232TS50000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 743982183 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43564	Bed transporter	A battery-powered device designed to be used by one healthcare provider to transport a hospital bed with steerable wheels with or without an occupant in a controlled manner within a hospital. It typically consists of a chassis, batteries, an operator handle with operating panel, a bed gripping claw, an electric motor that powers the drive wheel(s), a remote control for operation/steering, brakes, and an emergency stop button. The device is attached (locked) to one end of the bed and pulls the bed after it. It is compatible for transport in lifts and for long and short internal transports.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNL	Bed, Ac-Powered Adjustable Hospital

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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