Model, AEV, Ventilator, IDF

GUDID 00847946020668

Ventilator

Zoll Medical Corporation

Transport electric ventilator
Primary Device ID00847946020668
NIH Device Record Key52c4bf45-dcb2-47dd-8180-52d909a1b3ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel, AEV, Ventilator, IDF
Version Model Number799-AEV1-03
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847946020668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-28

Devices Manufactured by Zoll Medical Corporation

00847946026875 - X SERIES2025-12-15 X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12 LEAD W/INTERP, NO PACE, NO VOICE, NO ETCO2, NIBP, SPO2, TEMP/BVM, CPR EXPANSION PAC
00847946029777 - X SERIES2025-12-15 X SERIES, 12 LD, ALS, PACE, SPO2, CO2, NIBP, IBP/TEMP, CPR EXTENDED, DMST, REFURB
00847946029784 - X SERIES2025-12-15 X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, NIBP, SPO2, DMST, REFURB
00847946029791 - X SERIES2025-12-15 X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, NIBP, SPO2, CPR EXPANSION PACK, DMST, REFURB
00847946029807 - X SERIES2025-12-15 X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, NIBP, SPO2, CPR EXPANSION PACK, ETCO2, DMST, REFURB
00847946029814 - X SERIES2025-12-15 X SERIES MONITOR/DEFIBRILLATOR ,W/PACING, NELLCOR,12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, REFURB
00847946029821 - X SERIES2025-12-15 X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, DMST, REFURBISHED
00847946029838 - X SERIES2025-12-15 X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, SPO2, ETCO2, DMST, REFURB
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