FDA.reportPublic FDA data

SEAMLESS EXPANDABLE FOAM MATTRESS

Primary DI
00845699008001
Brand
SEAMLESS EXPANDABLE FOAM MATTRESS
Company
SIZEWISE RENTALS, L.L.C.
Model
SEAMLESS EXPANDABLE FOAM MATTRESS
Published
2021-03-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845699008001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699008001008456990080018456990080010845699008001

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

Contacts#

Phone, Email table
PhoneEmail
951-273-7888jcastro@sizewisemfg.com

Regulatory Flags#

DUNS number
967025602
Device count
1
Premarket exempt
true
Serial number
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
H93338036Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338436Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338442Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H9336200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
00810055884230ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884247ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884254ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884261ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884278ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884285ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884292ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884308ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884315ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884322ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884339ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884346ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884353ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884360ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00023601033093CAREX HEALTH BRANDSDrive Devilbiss HealthcareFNM2024-06-13
H93365077Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-04-16
H93364565Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-02-14
00190885000049MatrixMidtown Investments, LLCFNM2023-01-28
00190885000056MatrixMidtown Investments, LLCFNM2023-01-28
00190885000063MatrixMidtown Investments, LLCFNM2023-01-28
00190885000070MatrixMidtown Investments, LLCFNM2023-01-28
00190885000087MatrixMidtown Investments, LLCFNM2023-01-28
00190885000094MatrixMidtown Investments, LLCFNM2023-01-28
00190885000100MatrixMidtown Investments, LLCFNM2023-01-28