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

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose multi-parameter bedside monitorAn electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198953205716CARESCAPE Telemetry ServerGe Medical Systems Information Technologies, Inc.MHX2026-06-05
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00884838119024Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119031Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119048Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119055Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119062Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119185Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119192Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119208Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
20884838119769Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
20884838119776Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
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B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.MHX2024-12-19
B353UB25501UbiqVue MultiparameterLifesignals, Inc.MHX2024-11-29
10841522117688XHIBITSPACELABS HEALTHCARE (WASHINGTON), INCMHX2024-06-07
B353UA2550BG1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550C1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550MR1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550RB1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550S1UbiqVue Lifesignals, Inc.MHX2024-05-15
B353UA2550R1UbiqVue Lifesignals, Inc.MHX2024-05-06
B353UB15501UbiqVue MultiparameterLifesignals, Inc.MHX2024-05-06
00763000613747LINQ II™MEDTRONIC, INC.DSI2023-11-19