AccessGUDID - DEVICE: ACHEEVA LEARNING STATION (05050962153011)

GUDID

Device Identifier (DI) Information

Brand Name: ACHEEVA LEARNING STATION
Version or Model: STUDENT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FA3000
Company Name: THE HELPING HAND COMPANY (LEDBURY) LIMITED

Primary DI Number: 05050962153011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 397307240 *Terms of Use

Device Description: ACHEEVA LEARNING STATION

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):	Yes
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?
32153	Bed mattress support platform, electric	A mains electricity (AC-powered) medical bed structure that supports a medical bed patient surface (e.g., a mattress) and that can articulate and/or change its surface to facilitate various therapeutic, diagnostic, and convenience positions. It is typically a flat structure made of a metal frame that operates in response to an electrically-operated bed control device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use

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: e41112e5-59d3-4667-a683-6e091f99a6a5
Public Version Date: February 12, 2024
Public Version Number: 1
DI Record Publish Date: February 02, 2024