AccessGUDID - DEVICE: ThevoautoActive FR 297 lbs, Split King 38x79", inco lip. (04034089096698)

GUDID

Device Identifier (DI) Information

Brand Name: ThevoautoActive FR 297 lbs, Split King 38x79", inco lip.
Version or Model: 9800685110014
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft

Primary DI Number: 04034089096698
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317356343 *Terms of Use

Device Description: No description.

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?
63237	Foam bed mattress	A large, durable, fabric case filled with foam, which may be segmented/compartmentalised, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It may contain weight-distribution air cells. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKY	Mattress, Flotation Therapy, Non-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: e8148a81-ee00-4ed2-b7d3-b907e5913595
Public Version Date: December 21, 2023
Public Version Number: 1
DI Record Publish Date: December 13, 2023