FDA.report

Aeda

Primary DI
04897079030153
Brand
Aeda
Company
Aeda Healthcare Limited
Model
1M01M060059 Rev.E / MT-S4-025
Device description
CU MTA1.1 110US/2060/G-QR/CU/D-3cell MT-S4-025 W/packing
Published
2017-09-10
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

Related Records

Product Codes

CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04897079030153PackageGS14In Commercial Distribution
04897079030139PrimaryGS10

GMDN Terms

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

Contacts

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 DIBrandModelCatalogPublished
04897079030177Aeda3M01M060081 Rev.A / MT-A4-2312018-04-13
04897079030184Aeda2M01M060022 Rev.B / MT-C4-2312018-04-13
04897079030054Aeda3M01M060019 Rev.B / MT-A2-2102017-10-10
04897079030061Aeda1M01M060037 Rev.C / CU-A2-1552017-09-27
04897079030078Aeda3M01M0600232017-07-31
04897079030085AedaMT-A3-3012017-07-31
04897079030092Aeda3M01M060021 Rev.E / MT-A3-0212017-11-15
04897079030108Aeda2M01M060002 Rev.E / MT-S4-0252017-09-27
04897079030115Aeda3M01M060041 Rev.C / MT-A3-0252017-11-15
04897079030122Aeda2M01M060012 Rev.C / MT-S4-0352017-09-27
04897079030160AedaMT-A3-3002017-07-20

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