AccessGUDID - DEVICE: e2™ Ceiling Mount Trapeze with 24 in. Grab Bar (00689281010382)

GUDID

Device Identifier (DI) Information

Brand Name: e2™ Ceiling Mount Trapeze with 24 in. Grab Bar
Version or Model: STP-CM-24
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01038
Company Name: Healthcraft Products Inc.

Primary DI Number: 00689281010382
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252468293 *Terms of Use

Device Description: The e2 Ceiling Mount Trapeze is an over-bed trapeze system that secures to the ceiling. The trapeze handle features two offset ladder rungs to allow for improved use of arm strength and increased comfort. Additionally, it can slide sideward / laterally on the ceiling mounted grab bar to store out of the way when not in use. The e2 Ceiling Mount Trapeze is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. The grab bar is installed to a structural ceiling, and a metal hook is looped onto the grab bar. The trapeze handle is connected with an adjustable strap to the metal hook. The maximum user weight for this product is 300lbs / 136kgs. No more than 150lbs / 68kgs is to be exerted on the e2 trapeze (sitting support only). NOTE: Product is not intended to support full body weight.

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?
37510	Assistive patient lifting pole	A device designed as an overhead bar with a hanging handgrip above the occupant of the bed that is attached to a medical bed or secured to the wall behind the bed and used by the occupant to provide support when changing position or pulling themselves into a sitting position.	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: 69efde0a-c75f-4a0a-89ec-3e2d3ca9fc45
Public Version Date: December 23, 2024
Public Version Number: 2
DI Record Publish Date: August 25, 2021