Mega Vac Plus

GUDID 10614559102145

Mega Vac PLUS Smoke Evacuator with Laparoscopic Mode and Open Procedure Modes

MEGADYNE MEDICAL PRODUCTS, INC.

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Primary Device ID10614559102145
NIH Device Record Keybeff7a4e-d143-4d8e-a551-73487a6ae8f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMega Vac Plus
Version Model Number2200
Company DUNS185444825
Company NameMEGADYNE MEDICAL PRODUCTS, INC.
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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Phone+18015769669
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Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
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Phone+18015769669
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Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
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Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
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Phone+18015769669
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Phone+18015769669
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Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
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Phone+18015769669
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Phone+18015769669
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Phone+18015769669
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Phone+18015769669
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Phone+18015769669
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Phone+18015769669
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Phone+18015769669
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Phone+18015769669
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Phone+18015769669
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Phone+18015769669
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Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
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Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
Emailmegadyne.udi@megadyne.com
Phone+18015769669
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Phone+18015769669
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Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
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Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
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Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
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Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
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Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110614559102145 [Primary]

FDA Product Code

FYDAPPARATUS, EXHAUST, SURGICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-08
Device Publish Date2016-12-14

On-Brand Devices [Mega Vac Plus]

10614559102145Mega Vac PLUS Smoke Evacuator with Laparoscopic Mode and Open Procedure Modes
30614559102095Ulpa Filter w/fluid trap, Mega Vac Smoke Evacuator, Non sterile

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