AccessGUDID - DEVICE: AFFINITY MATTRESS V FOAM FOOT SECTION (00840828162722)

GUDID

Device Identifier (DI) Information

Brand Name: AFFINITY MATTRESS V FOAM FOOT SECTION
Version or Model: SM-AFFINITY-VFT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 14573
Company Name: CURBELL MEDICAL PRODUCTS, INC.

Primary DI Number: 00840828162722
Issuing Agency: GS1
Commercial Distribution End Date: January 08, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 796452311 *Terms of Use

Device Description: AFFINITY MATTRESS V FOAM FOOT SECTION

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: 9ddfacee-70a6-41d6-89e9-937ef8814da9
Public Version Date: January 09, 2019
Public Version Number: 2
DI Record Publish Date: October 04, 2018