AccessGUDID - DEVICE: Showering and changing table 1000 (05708590317977)

GUDID

Device Identifier (DI) Information

Brand Name: Showering and changing table 1000
Version or Model: R8402
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R8402000-93
Company Name: Pressalit A/S

Primary DI Number: 05708590317977
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305656662 *Terms of Use

Device Description: Showering and changing table 1000, 120V, electrically height adjustable with wired remote control, 1400 mm, with safety rail, white

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?
43600	Bathing/changing table, stationary	A raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off), either mounted on a fixed frame with legs or wall-mounted (may be height-adjustable), designed to support a recumbent patient for bathing, showering or changing. It is designed to be placed in an appropriate bathing area or where the patient can be given a body bath (washed by hand by assisting staff) or shower. The device is used primarily for a patient with a disability incapable of supporting themself in an upright position. It is designed to be stationary and is used in one location.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INQ	Table, Powered

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: 8a5cf95a-3053-43fe-bd1d-eb013109809f
Public Version Date: February 09, 2021
Public Version Number: 2
DI Record Publish Date: June 08, 2020