AED Manager, V.2.2.1.1 Powerheart G5 40-00296-05

GUDID 00812394021505

Event Reporting and Administrative AED Configuration Software V.2.2.1.1 for Powerheart G5

Zoll Medical Corporation

External defibrillator application software
Primary Device ID00812394021505
NIH Device Record Key07a2582d-34c2-4ed6-9470-76840e05e3b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAED Manager, V.2.2.1.1 Powerheart G5
Version Model Number40-00296-05
Catalog Number40-00296-05
Company DUNS055363428
Company NameZoll Medical Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Customer Support Contacts

Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com
Phone1.262.953.3500
Emailtechsupport@cardiacscience.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812394021505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKJAutomated External Defibrillators (Non-Wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-02-08
Device Publish Date2020-05-28

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00812394026326 - X SERIES2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM/TEMP, CPR EXPANSION PACK, US, REFU
00812394026333 - X SERIES2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, PACE, ETCO2, NIBP, SPO2/SPCO, BVM/TEMP, CPR EXPANSION PACK, US, REFU
00812394026364 - X SERIES2025-06-18 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 3/5 LEAD, SPO2, BVM, NIBP, CPR EXPANSION PACK, CANADIAN, REFURB, (TIER 2)
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