FDA.reportPublic FDA data

IsoAir

Primary DI
00841965103692
Brand
IsoAir
Company
Tridien Medical
Model
2940
Catalog number
SYS-SR-017
Device description
"Sys,SR,Aust,35x80x8"" "
Published
2017-01-13
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
00841965103692PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841965103692008419651036928419651036920841965103692

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress overlay systemAn assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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H93338442Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H9336200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
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00810055884247ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884254ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884261ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884278ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884285ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884292ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884308ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884315ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884322ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884339ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884346ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884353ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884360ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00023601033093CAREX HEALTH BRANDSDrive Devilbiss HealthcareFNM2024-06-13
H93365077Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-04-16
H93364565Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-02-14
00190885000049MatrixMidtown Investments, LLCFNM2023-01-28
00190885000056MatrixMidtown Investments, LLCFNM2023-01-28
00190885000063MatrixMidtown Investments, LLCFNM2023-01-28
00190885000070MatrixMidtown Investments, LLCFNM2023-01-28
00190885000087MatrixMidtown Investments, LLCFNM2023-01-28
00190885000094MatrixMidtown Investments, LLCFNM2023-01-28
00190885000100MatrixMidtown Investments, LLCFNM2023-01-28