FDA.reportPublic FDA data

N/A

Primary DI
57613327487621
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
HM34SPU
Catalog number
HM34SPU
Device description
HoverMatt 34" W x 78" L
Published
2019-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
57613327487621PackageGS110In Commercial Distribution
10817357020653PreviousGS10
07613327487626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332748762157613327487621
1081735702065310817357020653
07613327487626076133274876267613327487626

GMDN Terms#

Term, Definition table
TermDefinition
Patient transfer system, poweredA mains electricity (AC-powered) assembly of devices used to transfer a supine patient, typically from his/her bed or transport stretcher to an operating table or vice versa. It is usually installed in large operating room (OR) complexes and serves as a sluice providing demarkation between the OR staff and the ward staff/porters and related devices. It may be designed as a motorized belt that is wider than the length of the patient and that rotates around a moveable pick-up plate which feeds in under the patient, drawing him/her onto the belt and depositing him/her onto an adjacent surface. It is typically fully automated, requiring no human intervention other than to operate the controls.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length78Inch
Width34Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
020198912
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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