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

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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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