FDA.reportPublic FDA data

uCor Heart Failure and Arrhythmia Management System

Primary DI
00855778005456
Brand
uCor Heart Failure and Arrhythmia Management System
Company
ZOLL MANUFACTURING CORPORATION
Model
Gateway (4G)
Catalog number
10A1107
Published
2023-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSBPlethysmograph, ImpedanceCardiovascular2
DSIDetector And Alarm, ArrhythmiaCardiovascular2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172510000µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation2018-05-11MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855778005456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855778005456008557780054568557780054560855778005456

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
00855778005463ZOLL Arrhythmia Management SystemGateway (4G)10A11122023-06-22
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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04538612230387FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.DSI2026-07-17
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