ZOLL ePCR iOS

GUDID 00847946021924

Stand alone software used to collect, store and print patient data on various iOS devices

Zoll Medical Corporation

Medical equipment clinical data interfacing software
Primary Device ID00847946021924
NIH Device Record Key092f8cf6-ece6-4856-815d-78876a157d71
Commercial Distribution StatusIn Commercial Distribution
Brand NameZOLL ePCR iOS
Version Model NumberZEPCRU
Company DUNS055363428
Company NameZoll Medical Corporation
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100847946021924 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NSXSoftware, Transmission And Storage, Patient Data

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
Device Publish Date2017-03-17

Devices Manufactured by Zoll Medical Corporation

00847946033965 - ZENIX2024-11-21 CABLE, ECG 3 LEAD SET, IEC
00847946027018 - CPR ELECTRODE, GEMINI2024-11-11 ONESTEP PEDIATRIC CPR ELECTRODE, GEMINI, SINGLE
00847946094706 - VENT2024-07-26 ZVENT, FULL FEATURED, HOSPITAL SW w/CARRY CAGE, RENTAL PROGRAM
00847946023522 - VENT2024-07-16 VENTILATOR,EAGLE II,731 SERIES, REFURB
00847946023539 - VENT2024-07-16 VENTILATOR,EAGLE II,731 SERIES,MRI, REFURB
00847946023546 - VENT2024-07-16 VENTILATOR,EMV+,731 SERIES, REFURB
00847946094409 - VENT2024-07-16 VENTILATOR,AEV,731 SERIES
00847946094416 - VENT2024-07-16 AEV VENTILATOR SYSTEM, W/COMPRESSOR-AIR, OXYGEN MIXER, AC POWER SUPPLY, 6' HOSE, 12VDC CABLE, CIRCUTS, MRI, CPAP MASK & PADDED C

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