FDA.reportPublic FDA data

N/A

Primary DI
07613327487565
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
HM34RPSPU
Catalog number
HM34RPSPU
Device description
"HoverMatt 34"" W x 78"" L"
Published
2019-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
57613327487560PackageGS110In Commercial Distribution
10817357022527PreviousGS10
07613327487565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332748756057613327487560
1081735702252710817357022527
07613327487565076133274875657613327487565

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length78Inch
Width34Inch

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327688788N/APSCIC101PSCIC1012026-04-06
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
00850043377092Aquamantys23-112-123-112-12024-05-16
00850043377085Aquamantys23-313-123-313-12024-05-16
00850043377108Aquamantys23-113-123-113-12024-05-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
00885825011703N/AN/A4083092016-09-23
00885825011710N/AN/A4083102016-09-23
00885825011727N/AN/AG4083242016-09-23
07613327663365N/AHAR723HAR7232025-08-27
07613327663389N/AHAR736HAR7362025-08-27
07613327663419N/AHAR745HAR7452025-08-27
37613327663366N/AHAR723HAR7232025-08-27
37613327663380N/AHAR736HAR7362025-08-27
37613327663410N/AHAR745HAR7452025-08-27
07613327487640N/AHM39SPU-HLFHM39SPU-HLF2019-07-10
07613327487671N/AHM50RPSPUHM50RPSPU2019-07-10

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
10885380203145Sustainable TechnologiesCardinal Health 200, LLCFRZ2025-09-10
00816299012644HoverMatt PROS-AIRHovertech InternationalFRZ2025-09-10
00816299012651HoverMatt PROS Hovertech InternationalFRZ2025-09-10