AccessGUDID - DEVICE: Ease Cushion (00860002071220)

GUDID

Device Identifier (DI) Information

Brand Name: Ease Cushion
Version or Model: Standard Pump
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Ease Seating Systems

Primary DI Number: 00860002071220
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080264585 *Terms of Use

Device Description: Ease Cushion Standard Pump

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?
36688	Alternating-pressure inflator	An electrically-powered device that forces ambient air into the parallel chambers of an alternating-pressure bed mattress overlay or an alternating-pressure chair cushion, for the timed alternation of chamber inflation and thereby exchange of patient contact points. The inflator, which may be referred to as a pump and may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient.	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: 62deeb47-208c-4e63-9040-aa9e2699dc89
Public Version Date: September 19, 2024
Public Version Number: 4
DI Record Publish Date: July 28, 2020