FDA.reportPublic FDA data

Sizewise

Primary DI
00845699002641
Brand
Sizewise
Company
SIZEWISE RENTALS, L.L.C.
Model
ADP PULLAL3588
Device description
Pulsate LAL Adapt (Alliance)
Published
2024-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMRDevice, Transfer, Patient, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845699002641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699002641008456990026418456990026410845699002641

GMDN Terms#

Term, Definition table
TermDefinition
Flotation therapy bed, adultA mains electricity (AC-powered) bed designed to minimize pressure points on a patient's body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect. It is used in cases of decubitus ulcers or where a patient has little remaining body fat and the displacement of body weight is vital for treatment and/or comfort. It can also be used for the treatment badly burned patients and/or to aid circulation. The device may allow for the regulation of mattress temperature to enhance treatment.

Sterilization Methods#

Method table
Method

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860012736072Prism Lift Seated SlingPrism Pacific Industries LLCFMR2026-08-27
00860012736089Prism Lift Seated SlingPrism Pacific Industries LLCFMR2026-08-27
00860015694775Prism SlidePrism Pacific Industries LLCFMR2026-08-27
00860015694782Prism SlidePrism Pacific Industries LLCFMR2026-08-27
00199536930308BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00199536930315BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00199536930322BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00199536930339BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
00199536930346BluelineTransparent Supply Solutions Ltd.FMR2026-08-07
06973717276928GARVEEFoshan Dahao Medical Technology Co., Ltd.FMR2026-07-29
15059441537295AIRPALArjohuntleigh ABFMR2026-03-23
15059441537301AIRPALArjohuntleigh ABFMR2026-03-23
15059441537318AIRPALArjohuntleigh ABFMR2026-03-23
15059441537325AIRPALArjohuntleigh ABFMR2026-03-23
15059441537332AIRPALArjohuntleigh ABFMR2026-03-23
15059441537349AIRPALArjohuntleigh ABFMR2026-03-23
00810113682730ManaSlideManamed, Inc.FMR2025-11-25
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCFMR2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCFMR2025-11-19
0078755104129340649 Air-Assist +XODUS MEDICAL, INC.FMR2025-10-24
0078755104130940650 Air-Assist EXTXODUS MEDICAL, INC.FMR2025-10-24
10197344161249MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-07-11
20197344154958MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-04-23
10193489021141MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-02-14
0078755104000540685 Air Assist Power Lift - 120VACXODUS MEDICAL, INC.FMR2025-02-04
0078755104074640999 Air Assist Power Lift - 220VACXODUS MEDICAL, INC.FMR2025-02-04
10193489000658MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-01-03
10603354130200BAMEHOB INCFMR2024-09-12