FDA.reportPublic FDA data

Aeda

Primary DI
04897079030160
Brand
Aeda
Company
Aeda Healthcare Limited
Model
MT-A3-300
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 to
Published
2017-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04897079030160PackageGS14In Commercial Distribution
04897079030146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04897079030160048970790301604897079030160
04897079030146048970790301464897079030146

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure pumpA mains electricity (AC-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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2293441181wade@integritysl.net

Regulatory Flags#

DUNS number
680255366
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897079030139Aeda1M01M060059 Rev.E / MT-S4-0252017-09-10
04897079030146AedaMT-A3-3002017-07-20
04897079030061Aeda1M01M060037 Rev.C / CU-A2-1552017-09-27
04897079030085AedaMT-A3-3012017-07-31
04897079030108Aeda2M01M060002 Rev.E / MT-S4-0252017-09-27
04897079030122Aeda2M01M060012 Rev.C / MT-S4-0352017-09-27
04897079030184Aeda2M01M060022 Rev.B / MT-C4-2312018-04-13
04897079030177Aeda3M01M060081 Rev.A / MT-A4-2312018-04-13
04897079030054Aeda3M01M060019 Rev.B / MT-A2-2102017-10-10
04897079030078Aeda3M01M0600232017-07-31
04897079030092Aeda3M01M060021 Rev.E / MT-A3-0212017-11-15
04897079030115Aeda3M01M060041 Rev.C / MT-A3-0252017-11-15
04897079030153Aeda1M01M060059 Rev.E / MT-S4-0252017-09-10

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Primary DI, Brand, Company table
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00810055885718DOLPHIN FIS 35X82X10 AUTOVECTOR SYSTEM UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885725SYSTEM, 33X82X10, DOLPHIN PEDIATRIC, UKJOERNS HEALTHCARE, LLCFNM2026-08-26
00810055885732DOLPHIN 33.5 X 82 AUTOVECTOR SYSTEMJOERNS HEALTHCARE, LLCFNM2026-08-26
00810226442016ViveVIVE HEALTH LLCFNM2026-08-19
00810226442023ViveVIVE HEALTH LLCFNM2026-08-19
00810226442030ViveVIVE HEALTH LLCFNM2026-08-19
00850076421106ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
00850076421113ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
00850076421120ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
00850076421137ThinAIRTHIN AIR SURFACES, LLCFNM2026-07-31
H93359076Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-07-27
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04719893356434WellellWellell Inc.FNM2026-04-20
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H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13