FDA.reportPublic FDA data

Defibtech ARM XR Stabilization Strap

Primary DI
00815098020829
Brand
Defibtech ARM XR Stabilization Strap
Company
DEFIBTECH, L.L.C.
Model
RSS-U2000
Published
2023-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K211289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211289000RMU-2000 Automated Chest Compression SystemDefibtech, LLC2021-11-09DRM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815098020829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815098020829008150980208298150980208290815098020829

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac resuscitator, battery-poweredA battery-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)]. It may be available in a variety of forms but includes a mechanical chest compressor (e.g., plunger-type), a battery-powered control unit, and patient straps/supports. The device is typically used as an adjunct to or substitute for manual external cardiac compression in cases where manual compression is not ideal, or to prevent fatigue and improve consistency (i.e., of force, rate).

Regulatory Flags#

DUNS number
128340200
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815098020475DDU-1XX Series Adult Pads Adapter, Physio-Control ConfigurationDAC-300E2015-10-23
10815098020482DDU-1XX Series Adult Pads Adapter, Zoll ConfigurationDAC-310E2015-10-24
10815098020499DDU-1XXX/2XXX Adult Pads Adapter, Physio-Control ConfigurationDAC-20002015-10-24
10815098020505DDU-1XXX/2XXX Adult Pads Adapter, Zoll ConfigurationDAC-20102015-10-24
00815098020478DDU-1XX Series Adult Pads Adapters, Physio-ControlDAC-300E2015-10-24
00815098020485DDU-1XX Series Adult Pads Adapters, ZollDAC-310E2015-10-24
00815098020492DDU-1XXX/2XXX Series Adult Pads Adapter, Physio-ControlDAC-20002015-10-24
00815098020508DDU-1XXX/2XXX Series Adult Pad Adapters, ZollDAC-20102015-10-24
00815098021482Lifeline VIEW 2DDU-29502025-12-09
00815098021512Lifeline VIEW 2 AutoDDU-29552025-12-09
00815098021536Lifeline ECG 2DDU-29602025-12-09
00815098021550DDU-29XX series, universal pad, single pairDDP-20042025-12-09
10815098021496Lifeline VIEW 2 AED configurationDDU-29502025-12-09
10815098021526Lifeline VIEW 2 AUTO AED configurationDDU-29552025-12-09
10815098021540Lifeline ECG 2 AED configurationDDU-29602025-12-09
30815098021568Pads, DDU-29XX series, universal pad, 10 pairsDDP-20042025-12-09
50815098021579Pads, DDU-29XX series, universal pad, 40 pairsDDP-20042025-12-09
10815098020529DDU-2XXX Series ECGMA Cable, IEC ConfigurationDAC-20212015-10-24
00815098020522DDU-2XXX Series ECGMA Cable, IECDAC-20212015-10-24
00815098020010LifeforceDDU-100C2015-10-24

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
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
00860000876285ROSC-U Wheeled/Storage CaseRESUSCITATION INTERNATIONAL, LLCDRM2019-12-13