FDA.reportPublic FDA data

NA

Primary DI
00842307100072
Brand
NA
Company
GENDRON, INC.
Model
3642HC
Device description
"BED,HOMECARE 42 X 86"" 650 LB 3 FUNCTION BEECHWOOD FRAME,DECORATIVE STYLE HEADBOARD/FOOTBOARD OF CHOCOLATE PEAR COLOR,FULL PLASTIC SIDERAILS (HEAD END ONLY),FOOT END CONTROLS ON FOOTBOARD FOR BACKREST, LEG, BED, UP AND DOWN. ALSO LOCKOUTS FOR ANY OR ALL FUNCTIONS. "
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00842307100072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842307100072008423071000728423071000720842307100072

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

Regulatory Flags#

DUNS number
054164587
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842307100003NA1000MR-1242016-09-23
00842307100010NA1050-123-213-122-1512016-09-23
00842307100027NA11502016-09-23
00842307100034NA1150-123-213-1402016-09-23
00842307100041NA1190-1322016-09-23
00842307100058NA16002016-09-23
00842307100065NA3150-4043-62016-09-23
00842307100096NA36482016-09-23
00842307100102NA4000MRQ22016-09-23
00842307100119NA4748SB2016-09-23
00842307100126NA5154DX-12016-09-23
00842307100133NA5154PDX2016-09-23
00842307100140NA5322-18-62-36-P11882016-09-23
00842307100157NA5324-18-61-36-P11882016-09-23
00842307100164NA5424-18-61-36-P11882016-09-23
00842307100171NA6324-18-61-78-36-8-P11882016-09-23
00842307100188NA6424-18-61-78-36-8-P11882016-09-23
00842307100195NA6724-18-61-78-29-82016-09-23
00842307100201NA6724-18-62-78-28-82016-09-23
00842307100218NA6724-20-62-78-29-82016-09-23

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