FDA.reportPublic FDA data

Sizewise

Primary DI
00845699002269
Brand
Sizewise
Company
SIZEWISE RENTALS, L.L.C.
Model
EXPRM 394882
Device description
"Expandable Pressure Redistribution Mattress - 39""/48"""
Published
2024-08-06
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
00845699002269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699002269008456990022698456990022690845699002269

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattressA mattress-like device consisting of an arrangement of alternating-pressure air cells designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It is connected to an alternating-pressure pump (not included) which provides the inflation/deflation control. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers) patients, patients with disabilities, or patients with low body fat.

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
Primary DIBrandCompanyProduct codePublished
06972077023883CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024125CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024132CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024149CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024156CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024163CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024316CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077024323CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025030CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025047CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025054CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025061CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025078CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06972077025085CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06975084500675AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06975084500682AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06975084500699AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
06975084500705AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-24
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
06975084500095CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
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