AccessGUDID - DEVICE: Span-America (H933RDCL8436)

GUDID

Device Identifier (DI) Information

Brand Name: Span-America
Version or Model: CUSTOM CARE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RDCL8436
Company Name: SPAN-AMERICA MEDICAL SYSTEMS, INC.

Primary DI Number: H933RDCL8436
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073704413 *Terms of Use

Device Description: CL843629 STANDARD(0-1100 FT)

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?
63241	Alternating-pressure bed mattress system	An assembly of devices consisting of an alternating-pressure bed mattress (inflation-patterned air cells with or without foam component) and a dedicated electric pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNM	Mattress, Air Flotation, Alternating Pressure

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: 1b24a4a1-c808-4061-b8d0-e1bd17ebee42
Public Version Date: July 22, 2022
Public Version Number: 1
DI Record Publish Date: July 14, 2022