FDA.reportPublic FDA data

NA

Primary DI
00842307101390
Brand
NA
Company
GENDRON, INC.
Model
3875
Device description
BED, BARIATRIC EXPANDABLE LOW
Published
2016-11-11
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
00842307101390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842307101390008423071013908423071013900842307101390

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
00842307100072NA3642HC2016-09-23
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

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10190676006547POSEYPOSEY PRODUCTS, LLCFNL2022-10-06
10190676005588POSEYPOSEY PRODUCTS, LLCFNL2022-10-04
10190676005601POSEYPOSEY PRODUCTS, LLCFNL2022-10-04
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M368GS3648B1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
M368GS4842B1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
M368GS4842DNS1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
M368GS4842DW1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
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08592654186190Eleganza 3L I N E T spol. s r.o.FNL2018-09-18
08592654114766Eleganza 3L I N E T spol. s r.o.FNL2018-04-09
08592654134481Eleganza 5L I N E T spol. s r.o.FNL2018-04-09