uCor Heart Failure and Arrhythmia Management System 10A1073

GUDID 00855778005326

ZOLL MANUFACTURING CORPORATION

Single-patient intensive/general healthcare physiologic monitoring system
Primary Device ID00855778005326
NIH Device Record Key2d37d198-b770-43ea-870c-dff8e2ee3513
Commercial Distribution StatusIn Commercial Distribution
Brand NameuCor Heart Failure and Arrhythmia Management System
Version Model NumberGateway
Catalog Number10A1073
Company DUNS079320559
Company NameZOLL MANUFACTURING CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100855778005326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSBPlethysmograph, Impedance

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-06
Device Publish Date2019-05-17

On-Brand Devices [uCor Heart Failure and Arrhythmia Management System]

00855778005326Gateway
00855778005302Sensor
00855778005456Gateway (4G)

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