FDA.reportPublic FDA data

Burke Inc

Primary DI
B314633901
Brand
Burke Inc
Company
BURKE, INC.
Model
Tri-Flex Air
Catalog number
63390
Device description
Air Mattress, Low Air Loss
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
B314633901PrimaryHIBCC0

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
913-722-5658jernst@burke-mobility.com

Regulatory Flags#

DUNS number
045093101
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B313822501ScoutBoss 6NS822502016-09-01
B314150351PacesaverEspree Atlas150352016-09-01
B314150571PacesaverEspree Titan150572016-09-01
B314150631PacesaverPlus III Titan150632016-09-01
B314150671PacesaverPlus III Premier150672016-09-01
B314150681PacesaverEspree' Premier150682016-09-01
B314150701PacesaverPlus III Junior150702016-09-01
B314150721PacesaverEclipse Premier150722016-09-01
B314150731PacesaverEclipse Atlas150732016-09-01
B314150831PacesaverPlus III Atlas150832016-09-01
B314150851PacesaverFusion 450150852016-09-01
B314150861PaceSaverEspree Atlas 5150862016-09-01
B314150871PacesaverEclipse Atlas 5150872016-09-01
B314150901PacesaveFusion 500150902016-09-01
B314174771PacesaverFusion 350174772016-09-01
B314174781PaceSaverFusion 250174782016-09-01
B314634101Burke"Bari-Float Mattress 54"""634102016-09-01
B31481113A1ScoutRF - SP81113A2016-09-01
B314811221ScoutRF4811222016-09-01
B31481445A1ScoutM-1 81445A2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04719876192011TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-09
04719876190048TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190215TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190482TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876190499TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876191991TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192004TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192202TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
04719876192219TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNM2026-07-08
00841447116745Invacare MA500X4280MINVACARE CORPORATIONFNM2026-07-01
G771PDA91003680Pro-Daptive SensorCell Flotation SurfaceLEVISENSE MEDICAL, INC.FNM2026-06-09
00817012031874K-2oem ALT-AIRE+KAP MEDICALFNM2026-05-29
00817012031904K-4 D3XKAP MEDICALFNM2026-05-29
00817012031911K-4 D3XKAP MEDICALFNM2026-05-29
04719893356434WellellWellell Inc.FNM2026-04-20
H93338036Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338436Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338442Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H9336200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
04719893356922WellellWellell Inc.FNM2026-03-20
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
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