FDA.reportPublic FDA data

SUN

Primary DI
00845699005406
Brand
SUN
Company
WHEELCHAIRS OF KANSAS
Model
61350019
Device description
Pediatric Turn 120V
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
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
00845699005406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845699005406008456990054068456990054060845699005406

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress systemAn assembly of devices consisting of an alternating-pressure bed mattress (inflation-patterned air cells with or without foam component) and a dedicated electric pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063402450
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
00845699003822Mighty Rest 12060310 230V2026-05-08
00845699003723WOK6080-230V2024-09-20
00845699003501WOK4880-230V2024-09-13
00845699003518WOK3986-230V2024-09-13
00845699003792WOK120603092024-09-13
00845699003808WOK120603092024-09-13
00845699003815WOK120603102024-09-14
00845699003839WOK3980-230V2024-09-13
00845699004768WOK330603002024-08-30
00845699003532WOK230600102024-09-13
00845699003549WOK230602102024-09-13
00845699003556WOK230602202024-09-13
00845699003563WOK230600402024-09-13
00845699003570WOK180600002024-09-13
00845699003587WOK180600102024-09-13
00845699003495WOK3980-230V2024-09-13
00845699003631WOK616000602024-09-13
00845699003846WOK3580-115V2024-09-13
00845699003877WOK4280-230V2024-09-13
00845699003884WOK4286-230V2024-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15059441537295AIRPALArjohuntleigh ABFMR2026-03-23
15059441537301AIRPALArjohuntleigh ABFMR2026-03-23
15059441537318AIRPALArjohuntleigh ABFMR2026-03-23
15059441537325AIRPALArjohuntleigh ABFMR2026-03-23
15059441537332AIRPALArjohuntleigh ABFMR2026-03-23
15059441537349AIRPALArjohuntleigh ABFMR2026-03-23
00816299011500HoverCover SlideHovertech InternationalFMR2026-01-12
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
00816299012569HoverMatt PROS Hovertech InternationalFMR2025-09-10
00816299012576HoverMatt PROS Hovertech InternationalFMR2025-09-10
00816299012781HoverMatt PROS Hovertech InternationalFMR2025-09-10
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
10603354130248BAMEHOB INCFMR2024-09-12
10603354130262BAMEHOB INCFMR2024-09-12
10603354130286BAMEHOB INCFMR2024-09-12
10603354130309BAMEHOB INCFMR2024-09-12
10603354130323BAMEHOB INCFMR2024-09-03
10603354130347BAMEHOB INCFMR2024-09-03
10603354130361BAMEHOB INCFMR2024-09-03
10603354130446BAMEHOB INCFMR2024-09-03
10603354130514BAMEHOB INCFMR2024-09-03