FDA.reportPublic FDA data

Burke

Primary DI
B31463398B1
Brand
Burke
Company
BURKE, INC.
Model
Tri-Flex II
Catalog number
63398B
Device description
Bariatric Bed
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
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B31463398B1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bariatric bedA mains electricity (AC-powered) bed specifically designed as a bed to accommodate a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys, i.e., 500 kg total, including the weight of the mattress and other accessories. Features like size, shape, and patient comfort (both physical and mental) will be taken into consideration by the design. This device is electrically-operated to assist the user/attending staff to adjust the functions and positions of the bed. It will typically include adjustable height, back rest, knee-break, removable head and foot ends and possibly an integrated weighing facility.

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
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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

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08592654134481Eleganza 5L I N E T spol. s r.o.FNL2018-04-09