AccessGUDID - DEVICE: Span-America (H933MX84P0200429)

GUDID

Device Identifier (DI) Information

Brand Name: Span-America
Version or Model: Geomattress Max
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MX84P0200429
Company Name: SPAN-AMERICA MEDICAL SYSTEMS, INC.

Primary DI Number: H933MX84P0200429
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073704413 *Terms of Use

Device Description: MAX 84x35 Flat in Box

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?
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: 1b8dcd0b-454b-4701-a2a5-f42cb91d50c1
Public Version Date: December 12, 2022
Public Version Number: 1
DI Record Publish Date: December 02, 2022