DEVICE: R SERIES (04560233593107)

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Device Identifier (DI) Information

R SERIES
30001003101110362

Zoll Medical Corporation
04560233593107
GS1
1
Defibrillator ,MAIN, ALS, 3/5 LD, STD ECG, AC PWR, PACE, SPO2, ETCO2, CF/USB, JAPAN
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Physiologic-monitoring defibrillation system An assembly of electrically-powered devices designed to defibrillate the heart that incorporates additional therapeutic and/or monitoring features intended to resuscitate and/or monitor a cardiac patient. It typically includes devices that enable manual and/or automated external defibrillation (a defibrillator) and one or more of the following: electrocardiogram (ECG) monitoring (electrocardiograph), noninvasive cardiac pacing (temporary pacemaker), cardioversion (CV), pulse oximetry (oximeter), invasive and/or noninvasive blood pressure monitoring, and end-tidal carbon dioxide (EtCO2) monitoring (i.e., a CO2 monitor). It may have data recording/printing capabilities.
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FDA Product Code

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Product Code Product Code Name
DPS ELECTROCARDIOGRAPH
LDD Dc-defibrillator, low-energy, (including paddles)
DRO PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
MKJ Automated external defibrillators (non-wearable)
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 55 Degrees Celsius
Storage Environment Temperature: between -20 and 60 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 6.8" x 10.3" x 8.2"
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Device Status

In Commercial Distribution
April 29, 2015

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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