FDA.reportPublic FDA data

"Dynarex Bari + Max Bariatric Full Electric Home Care Bed 54"" Foot Deck"

Primary DI
00840117324718
Brand
"Dynarex Bari + Max Bariatric Full Electric Home Care Bed 54"" Foot Deck"
Company
Dynarex Corporation
Model
10403-FD-3
Published
2022-11-21
Public version status
Update
Distribution status
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
00840117324718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117324718008401173247188401173247180840117324718

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
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117307605Ever-Soft Pommel Gel Foam Cushion 18" x 16" x 3"106852021-04-22
00840117307629Ever-Soft Pommel Gel Foam Cushion 20" x 16" x 3"106862021-04-22
00840117307643Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106902021-04-22
00840117307667Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106912021-04-22
00840117307681Ever-Soft Pommel Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106802021-04-22
00840117307704Ever-Soft Pommel Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106812021-04-22
00840117352476Urinary Drainage Bag Holder 11" x 11" (27.9 cm x 27.9 cm)102612019-10-09
00616784065014Ever-Soft Foam Cushion 16" x 16" x 3"106502021-04-22
00616784065113Ever-Soft Foam Cushion 18" x 16" x 3"106512021-04-22
00616784065212Ever-Soft Foam Cushion 18" x 18" x 3"106522021-04-22
00616784065311Ever-Soft Foam Cushion 20" x 16" x 3"106532021-04-22
00616784065410Ever-Soft Foam Cushion 20" x 18" x 3"106542021-04-22
00840117307568Ever-Soft Coccyx Foam Cushion 18" x 16" x 3"106552021-04-22
00840117307582Ever-Soft Coccyx Foam Cushion 20" x 16" x 3"106562021-04-22
00840117326132Bariatric HD Patient Lift107072023-03-24
00616784067513Ever-Soft Alternating Pressure Air Cushion106752022-05-09
00616784042022DynaRest Multi-Zone Foam Mattress with Perimeter With Perimeter, 36" x 80" x 6"10420P2020-01-15
00616784070414Hydraulic Patient Lift107042019-09-30
00616784070018Electric Patient Lift107002019-09-25
00616784070117Bariatric Electric Patient Lift107012019-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977918410143SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNL2026-06-08
08592654283455Eleganza 5L I N E T spol. s r.o.FNL2022-12-21
M676MC7WSTMLB0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNL2022-11-08
10190676005557POSEYPOSEY PRODUCTS, LLCFNL2022-10-06
10190676006547POSEYPOSEY PRODUCTS, LLCFNL2022-10-06
10190676005588POSEYPOSEY PRODUCTS, LLCFNL2022-10-04
10190676005601POSEYPOSEY PRODUCTS, LLCFNL2022-10-04
07613327584745Sidekick SpraySTRYKER CORPORATIONFNL2022-02-28
10080196313877MedlineMEDLINE INDUSTRIES, INC.FNL2020-11-12
M368GS4054DW1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-06
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
07613327541243ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541250ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541267ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541274ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541281ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541298ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541304ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541328ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541335ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541342ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541359ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541366ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541373ProCuitySTRYKER CORPORATIONFNL2020-10-05
08592654185421Eleganza 3L I N E T spol. s r.o.FNL2018-10-29
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