M1743A

GUDID 00884838002104

Medium Switchless Internal Paddle

Philips Medical Systems

Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillator electrode, adult Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable Internal defibrillation electrode, adult, reusable
Primary Device ID00884838002104
NIH Device Record Keybe7ca54e-24e1-4957-95f1-b06b3ae1fc19
Commercial Distribution StatusIn Commercial Distribution
Version Model Number989803105061
Catalog NumberM1743A
Company DUNS078628040
Company NamePhilips Medical Systems
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 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

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838002104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDDDc-Defibrillator, Low-Energy, (Including Paddles)
MKJAutomated External Defibrillators (Non-Wearable)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

[00884838002104]

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[00884838002104]

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[00884838002104]

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[00884838002104]

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[00884838002104]

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[00884838002104]

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[00884838002104]

Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


[00884838002104]

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[00884838002104]

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Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


[00884838002104]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

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