Aeda

Basic Information

• Brand Name: Aeda
• Primary DI: 04897079030146
• Version / Model: MT-A3-300
• Company Name: Aeda Healthcare Limited
• Labeler DUNS: 680255366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-20
• Public Version: 3
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: 56eff434-04db-4abc-8cfd-dfb6082dfb72

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

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	880.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36688	Alternating-pressure pump	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 pump, which may be programmable, ensures a regular exchange of the overlay/cushion pressure points for the patient.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04897079030160	GS1	big carton	4	In Commercial Distribution
Primary	04897079030146	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]