FDA.reportPublic FDA data

AutoPulse NXT Resuscitation System

Primary DI
00849111003018
Brand
AutoPulse NXT Resuscitation System
Company
Zoll Circulation, Inc.
Model
Model 200
Catalog number
8700-001011
Device description
A Battery Charger is a standalone unit intended to charge and test-cycle the Nickel Metal Hydride Batteries.
Published
2023-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRMCompressor, Cardiac, External

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849111003018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849111003018008491110030188491110030180849111003018

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4085412140udisj@zoll.com

Regulatory Flags#

DUNS number
799455241
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849111076296VitalTemp™ VitalTemp™ Universal Pad, 2PK, US8700-0011312025-12-12
10849111076293VitalTemp™ VitalTemp™ Universal Pad, 2PK, US8700-0011312025-12-12
00849111076074Thermogard HQ Surface Start-Up KitSurface Start-Up Kit8700-000935-012024-05-22
00849111076081ThermoGard XP Surface Start-Up KitSurface Start-Up Kit8700-000936-012024-05-22
00849111076128Thermogard™ Vest, S/MS/M8700-000937-012024-05-22
00849111076135Thermogard™ Vest, L/XL L/XL8700-000938-012024-05-22
00849111076098STX SURFACE COOLING S/M PAD8700-000838-012024-08-15
00849111076104STX SURFACE COOLING L/XL PAD 8700-000839-012024-08-15
00849111076111STX SURFACE COOLINGTHIGHS ONLY PAD SET8700-000840-012024-08-15
00849111075787Thermogard XP, Lang set C, RohsThermogardHQ, Lang set C601337-0012023-01-17
00849111075794Thermogard XP, Lang set C, Rohs, RefurbThermogard XP, Lang set C, Rohs, Refurb2023-01-17
00849111075800Thermogard HQTM ConsoleThermogardHQ, Lang set A8700-001030-01 2022-06-27
00849111075862Thermogard HQTM Start-Up KitTG2-500D8700-001027-012022-06-27
00849111075879Thermogard HQTM Start-Up Kit EXTG2-500D, Extended Length8700-001028-012022-06-27
00849111050029Start-Up KitCG-500D8700-0666-032015-03-31
00849111050043ICY-3, Japan, Final Packaged Kit (Applause) IC-38938700-0657-032016-10-10
00849111050050Quattro, Japan, Final Packaged Kit (Applause) IC-45932016-10-10
00849111050074Cool Line® Intravascular Heat Exchange Catheter Kit (Applause)N/A8700-0654-032015-03-31
00849111050081Start-Up Kit JapanCG-500D8700-0785-032016-10-10
00849111075008Thermogard XP®Thermogard XP, Lang set B, Rohs2015-03-31

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