FDA.reportPublic FDA data

Sizewise

Primary DI
00845699004010
Brand
Sizewise
Company
SIZEWISE RENTALS, L.L.C.
Model
47060250
Device description
Low Profile BHB Platform Bed (Coco w/ restraint holes)
Published
2024-09-13
Public version status
New
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
00845699004010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699004010008456990040108456990040100845699004010

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
967025602
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
00845699004942Mighty Rest Blower613550122026-05-08
00845699046430Agiliti - Essentia65-05-00002026-05-08
00845699046447Agiliti - Essentia65-05-00102026-05-08
00845699046454Agiliti - Capillaire CP-1020822026-05-08
00845699046461Agiliti - Capillaire CP-1018842026-05-08
00845699046478Agiliti - Capillaire CP-1023822026-05-08
00845699046485Agiliti - Capillaire CP-1023402026-05-08
00845699046492Agiliti - Capillaire CP-1020462026-05-08
00845699046515Agiliti - Capillaire CP-2033842026-05-08
00845699046522Agiliti - Capillaire CP-2026652026-05-08
00845699046539Agiliti - Capillaire CP-2026502026-05-08
00845699046546Agiliti - Capillaire 067-005-0102502026-05-08
00845699046386Agiliti HealthMedical Bed (FNL)2024-09-20
00845699008117Sizewise Manufacturing500601002024-09-20
00845699003525WOK4886-230V2024-09-13
00845699003730WOK5486-230V2024-09-13
00845699003747WOK6086-230V2024-09-13
00845699008124Sizewise Manufacturing500601502024-09-13
00845699004782Sizewise330605102024-08-30
00845699002238SizewiseBRP3 3948802024-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06972077025047CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025054CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
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06975084500682AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
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00841447197966INVACARE® DLX SERIES BED RAILINVACARE CORPORATIONFNL2026-09-22
00841447198048INVACARE® THINKSOFT® POSITIONING DEVICEINVACARE CORPORATIONFNL2026-09-22
06972077025191CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500071SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500088DALTONXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
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06975084500415SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500422SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500439SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500446SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500453SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500460SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19