AccessGUDID - DEVICE: Assista-Rail (00689281001472)

GUDID

Device Identifier (DI) Information

Brand Name: Assista-Rail
Version or Model: AST-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00147
Company Name: Healthcraft Products Inc.

Primary DI Number: 00689281001472
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252468293 *Terms of Use

Device Description: The Assista-Rail is a fixed bed rail. The Assista-Rail is intended ONLY for minimal vertical load bearing to provide bed positioning and seating support for people with reduced mobility. The Assista-Rail is intended for home use. The Assista-Rail is installed between the mattress and box spring, and is secured in place with a safety strap. The Assista-Rail is height adjustable to accommodate the thickness of the mattress. The maximum user weight for this product is 300lbs / 136kgs. 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?
34868	Bedrail	A rigid, adjustable device that is mounted to the side or sides of a medical bed and, when in an "up" position, identifies the edge of the mattress support platform, providing a physical barrier intended to reduce the risk of accidental patient falls out of the bed. It may also enable the patient to independently sit up and/or change position while in bed. It may be a detachable component of the bed or integral to the overall construction of the bed. It is typically made of metal and/or plastic materials and is constructed to either lower or fold when the occupant vacates the bed or when not in use. It is not intended to be a patient restraint.	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: 89907df1-7173-4222-81a2-bd2501d36e19
Public Version Date: September 02, 2021
Public Version Number: 1
DI Record Publish Date: August 25, 2021