FDA.reportPublic FDA data

ZOLL Arrhythmia Management System

Primary DI
00855778005463
Brand
ZOLL Arrhythmia Management System
Company
ZOLL MANUFACTURING CORPORATION
Model
Gateway (4G)
Catalog number
10A1112
Published
2023-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
DSIDetector And Alarm, Arrhythmia
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190939000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190939000ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation2019-12-19MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855778005463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855778005463008557780054638557780054630855778005463

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079320559
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855778005272Hospital Wearable DefibrillatorHWD 1000 Therapy Electrode10A10092017-06-13
00855778005456uCor Heart Failure and Arrhythmia Management SystemGateway (4G)10A11072023-06-22
00855778005357ZOLL Arrhythmia Management SystemSensor10A10872020-10-21
00855778005364ZOLL Arrhythmia Management SystemGateway10A10882020-10-21
00855778005258ZOLL PatchPatch10A10672019-05-17
00855778005302uCor Heart Failure and Arrhythmia Management SystemSensor10A10712019-05-17
00855778005319ZOLL ChargerCharger10A10722019-05-17
00855778005326uCor Heart Failure and Arrhythmia Management SystemGateway10A10732019-05-17
00855778005432LifeVest Wearable DefibrillatorLifeVest Garment B (2.3)10A10952024-08-21
00855778005449LifeVest Wearable DefibrillatorLifeVest Garment B (2.4)10A10962024-08-21
00855778005371LifeVest Wearable DefibrillatorLifeVest 5100 Monitor10A10822024-08-19
00855778005388LifeVest Wearable DefibrillatorLifeVest 5100 Electrode Belt10A10862024-08-19
00855778005395LifeVest Wearable DefibrillatorLifeVest 5100 Battery Charger10A10832024-08-19
00855778005401LifeVest Wearable DefibrillatorLifeVest 5100 Battery Pack10A10842024-08-19
00855778005210LifeVest Wearable DefibrillatorLifeVest 4000 Battery Charger10A10432020-08-11
00855778005005LifeVest Wearable DefibrillatorLifeVest 4000 Monitor10A09882014-09-24
00855778005012LifeVest Wearable DefibrillatorLifeVest 4000 Electrode Belt10A09872014-09-24
00855778005029LifeVest Wearable DefibrillatorLifeVest 4000 Battery Charger10A09852014-09-24
00855778005036LifeVest Wearable DefibrillatorLifeVest 4000 Battery Pack10A09892014-09-24
00855778005043LifeVest Wearable DefibrillatorLifeVest 3000 Battery Pack10A08942015-02-27

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Primary DI, Brand, Company table
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00884838102866Telemetry Monitor 5500Philips Medizin Systeme Böblingen GmbHMHX2026-10-15
06944413809468Connection CableEdan Instruments, Inc.MHX2026-10-15
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMHX2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDSI2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMHX2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDSI2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMHX2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDSI2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDSI2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMHX2026-10-04
04538612061813FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612061820FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
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04538612916663FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916670FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916687FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
04538612916694FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-09-28
06944413835153Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.MHX2026-08-26
B353UB25511UbiqVue MultiparameterLifesignals, Inc.MHX2026-07-20
04538612151569FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612161049FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612209543FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17