FDA.reportPublic FDA data

Sustainable Technologies

Primary DI
10885380203114
Brand
Sustainable Technologies
Company
Cardinal Health 200, LLC
Model
ST-RGMT34HLF-REG
Catalog number
ST-RGMT34HLF-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
50885380203112PackageGS110In Commercial Distribution
10885380203114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538020311250885380203112
1088538020311410885380203114

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840216128774ASP Global / PrimoAsp Global, LLCFRZ2026-09-04
00860016315631Prism Air CartPrism Pacific Industries LLCFRZ2026-08-27
00860016216051Prism Glide RepoPrism Pacific Industries LLCFRZ2026-08-12
00810226440722ViveVIVE HEALTH LLCFRZ2026-08-03
06973717276935GARVEEFoshan Dahao Medical Technology Co., Ltd.FRZ2026-07-29
06973852599326Hi-FortuneKunshan Hi-Fortune Health Products Co.,LtdFRZ2026-07-22
00199874887180Prism AirPrism Pacific Industries LLCFRZ2026-07-10
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