AccessGUDID - DEVICE: ThevoCalm FR 176 lbs, Split King 38x79", jersey white (04034089092638)

GUDID

Device Identifier (DI) Information

Brand Name: ThevoCalm FR 176 lbs, Split King 38x79", jersey white
Version or Model: 9800672160044
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft

Primary DI Number: 04034089092638
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?
47520	Orthopaedic bed mattress	A large, durable, fabric case filled with a combination of layered resilient materials (e.g., foam rubber and gel) designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and to promote therapeutic postures in users suffering back maladies (e.g., spinal column compression, back pain) through the homogenous distribution of body weight.	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: f12bafae-69a8-4753-99f5-9a5d100f72ec
Public Version Date: May 08, 2023
Public Version Number: 1
DI Record Publish Date: April 28, 2023