FDA.reportPublic FDA data

SenTech

Primary DI
00841965103524
Brand
SenTech
Company
Tridien Medical
Model
Air Chair
Catalog number
77-SM22BAC
Device description
BedsideAirChairOverlay/Coverle
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00841965103524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841965103524008419651035248419651035240841965103524

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure chair cushion systemAn assembly of devices consisting of an alternating-pressure chair cushion and a dedicated pump, which also functions as the control unit, designed to actively change an occupant's buttocks-chair contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 800 474 4225info@tridien.com

Regulatory Flags#

DUNS number
625060962
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841965100486IsoAir294045A-SR5-35842017-01-13
00841965100493IsoAir294045A-SR5-32802017-01-13
00841965100509IsoAir294045A-SR5-35802017-01-13
00841965100516IsoAir294045A-SR8-32802017-01-13
00841965100523IsoAir294045A-SR8-35802017-01-13
00841965100554SenTechAir Chair77-SM22BAC-B2017-01-27
00841965100592Stryker Air286160SM-20002017-01-13
00841965100608IsoAir294012SM-SRLV-BH2017-01-13
00841965100615IsoAir294012SM-USLV-KIT2017-01-13
00841965100622IsoAir2940SYS-SR-0022017-01-13
00841965100653SenTechSentry 125012-SM50-R2016-09-19
00841965100660IsoAir294012SM-EUHV-KIT2017-01-13
00841965100677IsoAir294012SM-SALV-KIT2017-01-13
00841965100684Stryker Air286160SM-30002017-01-13
00841965100691IsoAir294012SM-SRHV-E2017-01-13
00841965100707Stryker Air286260SM-40002017-01-13
00841965100714IsoAir294012SM-SRHV-G2017-01-13
00841965100721Stryker Air286260SM-40012017-01-13
00841965100745IsoAir294012SM-SRHV-I2017-01-13
00841965100752IsoAir294012SM-SRHV-J2017-01-13

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