uCor Heart Failure and Arrhythmia Management System 10A1107

GUDID 00855778005456

ZOLL MANUFACTURING CORPORATION

General-purpose multi-parameter bedside monitor
Primary Device ID00855778005456
NIH Device Record Key1acdda57-4563-42d5-a33f-166b474be929
Commercial Distribution StatusIn Commercial Distribution
Brand NameuCor Heart Failure and Arrhythmia Management System
Version Model NumberGateway (4G)
Catalog Number10A1107
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
GS100855778005456 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-30
Device Publish Date2023-06-22

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

00855778005326Gateway
00855778005302Sensor
00855778005456Gateway (4G)

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