FDA.report

N/A

Primary DI
57613327487652
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
HM34SPU-LNK-B
Catalog number
HM34SPU-LNK-B
Device description
HoverMatt LINK 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

Related Records

Contact Domains

Product Codes

CodeName
FRZDEVICE, PATIENT TRANSFER, POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
FRZDevice, Patient Transfer, PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
57613327487652PackageGS110In Commercial Distribution
10817357022565PreviousGS10
07613327487657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
5761332748765257613327487652
1081735702256510817357022565
07613327487657076133274876577613327487657

GMDN Terms

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

TypeValueUnit
Length78Inch
Width34Inch

Sterilization Methods

Method

Contacts

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

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07613327688764N/AAFR-00006AFR-000062026-02-10
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
37613327663366N/AHAR723HAR7232025-08-27
37613327663380N/AHAR736HAR7362025-08-27
37613327663410N/AHAR745HAR7452025-08-27
07613327679571N/AD128622D1286222025-05-21
07613327666762N/A9898031450519898031450512025-02-24
07613327666786N/A9898031990719898031990712025-02-24
57613327666804N/A9898031975119898031975112025-02-24
07613327666939N/A9898032111719898032111712025-02-24
57613327664084Philips Healthcare014R014R2025-02-11
57613327664091Philips Healthcare85900P85900P2025-02-11
57613327664107Philips Healthcare85900PST85900PST2025-02-11
57613327664114Philips Healthcare88901889012025-02-11
57613327383923N/AN/A5921-024-145RP2019-08-04
57613327383930N/AN/A5921-030-135RP2019-08-04
57613327383947N/AN/A5921-030-236RP2019-08-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
10841962119464Symphony Locating Bar, PH StyleQfixFRZ2025-10-23
B237ZEPAUB800Zephyr Patient Positioning and Transfer SystemDiacor, Inc.FRZ2025-09-26
00841962120340Edge Guide SystemQfixFRZ2025-09-11
B237ZEPATG030Zephyr Patient Positioning and Transfer SystemDiacor, Inc.FRZ2025-08-13
00841962119481Symphony™QfixFRZ2025-07-09
00841962119498AirDrive Trolley™QfixFRZ2025-07-09
00841962119528AirShuttle Locating BarQfixFRZ2025-07-09
00841962119535AirShuttle Locating BarQfixFRZ2025-07-09
00841962119542AirShuttle Transfer HandleQfixFRZ2025-07-09
00841962119559InfinityLock™QfixFRZ2025-07-09
00841962119573AirShuttle Transfer HandleQfixFRZ2025-07-09
00841962119580InfinityLock™QfixFRZ2025-07-09
00841962119597AltaQfixFRZ2025-07-09
00841962119603AltaQfixFRZ2025-07-09
00841962119726AltaQfixFRZ2025-07-09
00841962119733AltaQfixFRZ2025-07-09
00841962119740AltaQfixFRZ2025-07-09
00841962119757InfinityLock™QfixFRZ2025-07-09
00841962119764AltaQfixFRZ2025-07-09
B237ZEP50Zephyr Patient Positioning and Transfer SystemDiacor, Inc.FRZ2025-03-27