AccessGUDID - DEVICE: Accora FloorBed 6 Bed Lever Assist Bar (05056147700476)

GUDID

Device Identifier (DI) Information

Brand Name: Accora FloorBed 6 Bed Lever Assist Bar
Version or Model: Bed Lever Assist Bar
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STLEV-0-FL6-100
Company Name: ACCORA LIMITED

Primary DI Number: 05056147700476
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 736558755 *Terms of Use

Device Description: FloorBed / Empresa Standard Bed Lever Assist Bar, FB6

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?
61456	Patient repositioning lever-board	A portable, manual device intended to be used by a healthcare provider(s) to assist the repositioning of a patient from supine to a seated position. It is a board/frame with handles that is shaped with a turn which functions as a pivot point to lever the patient from horizontal position (i.e., foetal-type position with legs supported over the bed edge) to a vertical position (i.e., seated); it may also be used to reposition the patient to a supine position.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKX	Aid, Transfer

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: 07f37020-1bc2-443b-803b-427ed6e1934d
Public Version Date: January 20, 2023
Public Version Number: 1
DI Record Publish Date: January 12, 2023