FDA.reportPublic FDA data

Sustainable Technologies

Primary DI
10885380203145
Brand
Sustainable Technologies
Company
Cardinal Health 200, LLC
Model
ST-RGMT50FL-REG
Catalog number
ST-RGMT50FL-REG
Device description
Regard HoverMatt® SPU Air Transfer Mattress
Published
2025-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRZDEVICE, PATIENT TRANSFER, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRZDevice, Patient Transfer, PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380203143PackageGS15In Commercial Distribution
10885380203145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538020314350885380203143
1088538020314510885380203145

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable patient transfer sliding mattress, reprocessedAn inflatable device designed to: 1) support a recumbent patient on a bed or table; and 2) assist healthcare professionals in the physical movement and transfer of a patient (e.g., hospitalized, disabled, geriatric) from one place to another using sliding techniques. It includes patient straps, handles for transfer, air hose inlets, and requires a pump (not included) for inflation; it is not intended for patient lifting. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816299013191HoverSling Repositioning SheetHovertech InternationalFRZ2026-05-12
00816299013214HoverMatt SPU LinkHovertech InternationalFRZ2026-05-12
00816299013238HoverMatt SPU LinkHovertech InternationalFRZ2026-05-12
00816299013252HoverMatt SPU LinkHovertech InternationalFRZ2026-05-12
00816299013276HoverSling Repositioning SheetHovertech InternationalFRZ2026-05-12
00816299012965HoverMatt PROS AirHovertech InternationalFRZ2026-02-27
00816299012989HoverMatt PROS AirHovertech InternationalFRZ2026-02-27
00816299013030HoverMatt PROS Air SlingHovertech InternationalFRZ2026-02-27
00816299012958HoverMatt PROS AirHovertech InternationalFRZ2026-02-27
00816299012972HoverMatt PROS AirHovertech InternationalFRZ2026-02-27
00816299012996HoverMatt PROS AirHovertech InternationalFRZ2026-02-27
00816299013047HoverMatt PROS Air SlingHovertech InternationalFRZ2026-02-27
00841962120456Alta for HexaPODQfixFRZ2026-01-14
00816299013016HoverMatt PROS Air SlingHovertech InternationalFRZ2026-01-12
B237ZEPACR110Zephyr Patient Positioning and Transfer SystemDiacor, Inc.FRZ2025-12-23
00841962120388Lumen AirShuttleQfixFRZ2025-12-02
00841962120395Symphony Locating Bar, PH StyleQfixFRZ2025-12-02
B237ZCPAST100Zephyr Patient Positioning and Transfer SystemDiacor, Inc.FRZ2025-11-13
10841962119457Symphony Locating Bar, Prodigy2™QfixFRZ2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixFRZ2025-10-23
10193489121117MEDLINEMEDLINE INDUSTRIES, INC.FRZ2025-10-15
10193489121124MEDLINEMEDLINE INDUSTRIES, INC.FRZ2025-10-15
B237ZEPAUB800Zephyr Patient Positioning and Transfer SystemDiacor, Inc.FRZ2025-09-26
00841962120340Edge Guide SystemQfixFRZ2025-09-11
10885380203114Sustainable TechnologiesCardinal Health 200, LLCFRZ2025-09-10
10885380203121Sustainable TechnologiesCardinal Health 200, LLCFRZ2025-09-10
10885380203138Sustainable TechnologiesCardinal Health 200, LLCFRZ2025-09-10
00816299012644HoverMatt PROS-AIRHovertech InternationalFRZ2025-09-10
00816299012651HoverMatt PROS Hovertech InternationalFRZ2025-09-10
00816299012682HoverMatt PROS Hovertech InternationalFRZ2025-09-10