AccessGUDID - DEVICE: Shuttle Series B - Standard (00845699001064)

GUDID

Device Identifier (DI) Information

Brand Name: Shuttle Series B - Standard
Version or Model: T1000-ST
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SIZEWISE RENTALS, L.L.C.

Primary DI Number: 00845699001064
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 967025602 *Terms of Use

Device Description: 120V Shuttle Series B 32" - LTC

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):	No
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?
58419	Mobile bariatric examination/treatment chair, electric	A mobile (on wheels) electronic device designed to support in a seated position an ambulatory or non-ambulatory bariatric (obese) patient, whose body mass exceeds the safe working load of a standard hospital/institution chair (e.g., around 350 kg), for examination/treatment. It incorporates a heavy-duty framework, extra wide seat-support for the patient, and an integrated rechargeable battery pack that powers electromotive functions (e.g., raise/lower/tilt/adjustment functions, motorized wheels). It is designed to be moved by healthcare professional for patient transport to a site for patient support without transfer during outpatient examination/treatment (e.g., surgical, dental, ENT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMR	Device, Transfer, Patient, Manual

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: 3379d445-eccb-4aa1-9458-b5e04305858b
Public Version Date: September 29, 2020
Public Version Number: 4
DI Record Publish Date: February 06, 2019