FDA.reportPublic FDA data

Burke

Primary DI
B314631871
Brand
Burke
Company
BURKE, INC.
Model
"Bari-Float Mattress 48"""
Catalog number
63187
Device description
"Foam Mattress w/ bolsters - 48"""
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
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B314631871PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bed mattressA large, durable, fabric case filled with a combination of layered resilient materials (e.g., foam rubber and gel) designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and to promote therapeutic postures in users suffering back maladies (e.g., spinal column compression, back pain) through the homogenous distribution of body weight.

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
00670482001101oneNEST SUmano Medical IncIKY2026-07-31
00670482001118oneNEST SUmano Medical IncIKY2026-07-31
H93383478Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2026-07-13
00887761010901Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010918Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010925Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
05059441461654TherarestArjohuntleigh ABIKY2026-02-10
00810178885084ViveVIVE HEALTH LLCIKY2026-02-02
00810178885091ViveVIVE HEALTH LLCIKY2026-02-02
H93353893Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-12-01
08592654851067Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851074Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851081Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
00841447115175Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115182Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115199Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115205Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
05056147701497Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701503Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701510Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701527Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701534Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701541Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701558Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701565Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701572Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701589Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701596Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701602Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
H93331629Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04