AccessGUDID - DEVICE: Aeda (04897079030085)

GUDID

Device Identifier (DI) Information

Brand Name: Aeda
Version or Model: MT-A3-301
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aeda Healthcare Limited

Primary DI Number: 04897079030085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 680255366 *Terms of Use

Device Description: This medical device is an Air Pump, and also named as Alternating Control Unit or Alternating-Pressure Pump, it is always used with an Air Mattress together, and combines into a Mattress System (Alternating Air Pressure Mattress), its function is controlling the Air Mattress to be inflated and deflated alternatively with a setting cycle time.

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: c9a26395-87d8-4abb-a8c8-fa97f5352b41
Public Version Date: September 19, 2024
Public Version Number: 4
DI Record Publish Date: July 31, 2017