FDA.reportPublic FDA data

Lucas PCI Back Plate

Primary DI
00883873948286
Brand
Lucas PCI Back Plate
Company
Jolife AB
Model
11576
Catalog number
11576-000064
Device description
LUCAS PCI BACK PLATE
Published
2014-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRMCOMPRESSOR, CARDIAC, EXTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRMCompressor, Cardiac, ExternalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090422000LUCAS 2Jolife AB2009-06-17DRM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883873948286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883873948286008838739482868838739482860883873948286

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac resuscitator, line-poweredA mains electricity (AC-powered), external device designed for the application of rhythmic compression to the chest in the region of the heart to provide blood flow during treatment of cardiac arrest [cardiopulmonary resuscitation (CPR)]. The device may consist of a solid base with an attached band that straps across the patient's chest to produce the compressions, or have other configurations. The device is typically used as an adjunct to or substitute for manual external cardiac compression, to prevent fatigue and to provide better consistency in the applied force and rate of compression.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-1142rs.seacustomersupport@physio-control.com

Regulatory Flags#

DUNS number
632662933
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883873834282LUCAS CPR Chest Compression System9957699576-0000672024-11-08
00883873970904Lucas Battery Pack1157611576-0000392014-12-04
00883873861820LUCAS CHEST COMPRESSION SYSTEM1157611576-0000802016-11-14
00883873826300LUCAS CHEST COMPRESSION SYSTEM9957699576-000063U2024-05-07
00883873826584LUCAS CHEST COMPRESSION SYSTEM9957699576-000043U2024-05-07
00883873881453NA1157611576-0000712019-04-30
00883873948323NA1157611576-0000602019-04-30
00883873834329LUCAS9957699576-0000632018-03-31
00883873861875LUCAS™ CHEST COMPRESSION SYSTEM9957699576-0000432016-11-14
00883873904565LUCAS™ Chest Compression System9957699576-0000242014-12-04
00883873970898Lucas Battery Pack1157611576-0000392014-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10815098020819Defibtech ARM XR Compression Module ConfigurationDEFIBTECH, L.L.C.DRM2025-03-25
00883873834282LUCAS CPR Chest Compression SystemJolife ABDRM2024-11-08
00883873762370LUCAS CHEST COMPRESSION SYSTEMPHYSIO-CONTROL, INC.DRM2024-05-31
00883873762387LUCASPHYSIO-CONTROL, INC.DRM2024-05-31
00883873826300LUCAS CHEST COMPRESSION SYSTEMJolife ABDRM2024-05-07
00883873826584LUCAS CHEST COMPRESSION SYSTEMJolife ABDRM2024-05-07
00849111002998AutoPulse Li-ion BatteryZoll Circulation, Inc.DRM2023-10-17
00849111003032AutoPulse NXTZoll Circulation, Inc.DRM2023-10-17
10849111002988LifeBand® Load-distributing BandZoll Circulation, Inc.DRM2023-10-17
00849111002981LifeBand® Load-distributing BandZoll Circulation, Inc.DRM2023-10-16
00849111003018AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.DRM2023-10-13
00849111003025AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.DRM2023-10-13
00849111003049AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.DRM2023-10-13
00849111003384AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.DRM2023-10-13
00849111003568AutoPulse NXT Multi-Chemistry Battery ChargerZoll Circulation, Inc.DRM2023-10-13
00815098020812Defibtech ARM XR Compression ModuleDEFIBTECH, L.L.C.DRM2023-01-25
00815098020829Defibtech ARM XR Stabilization StrapDEFIBTECH, L.L.C.DRM2023-01-25
00815098020836Defibtech ARM XR Suction Cup DEFIBTECH, L.L.C.DRM2023-01-25
00849111003223AutoPulse®Resuscitation SystemZoll Circulation, Inc.DRM2022-08-15
10849111003053AutoPulse®Resuscitation SystemZoll Circulation, Inc.DRM2022-08-15
00847946024048REUSABLE AIRWAY ADAPTERZoll Medical CorporationDRM2021-10-05
00847946024055REUSABLE AIRWAY ADAPTERZoll Medical CorporationDRM2021-10-05
00860000876209ROSC-U SystemRESUSCITATION INTERNATIONAL, LLCDRM2019-12-13
00860000876216ROSC-U, Battery Control UnitRESUSCITATION INTERNATIONAL, LLCDRM2019-12-13
00860000876223ROSC-U, CompressorRESUSCITATION INTERNATIONAL, LLCDRM2019-12-13
00860000876230ROSC-U, Disposables Pack (10)RESUSCITATION INTERNATIONAL, LLCDRM2019-12-13
00860000876247ROSC-U, Disposables Pack (5)RESUSCITATION INTERNATIONAL, LLCDRM2019-12-13
00860000876254ROSC-U Battery ChargerRESUSCITATION INTERNATIONAL, LLCDRM2019-12-13
00860000876261ROSC-U Head StabilizerRESUSCITATION INTERNATIONAL, LLCDRM2019-12-13
00860000876278ROSC-U Carrying/Storage CaseRESUSCITATION INTERNATIONAL, LLCDRM2019-12-13