DEVICE: X SERIES (04560233593534)

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Device Identifier (DI) Information

X SERIES
610-2441511-36

Zoll Medical Corporation
04560233593534
GS1
1
MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, VOICE, NIBP, SPO2, SPCO, SPMET, IBP/TEMP CPR EXPANSION PACK AND ETCO2, FREN JAPANESE
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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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
DRT MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
DQA Oximeter
MKJ Automated external defibrillators (non-wearable)
CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
DRO PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
DSK COMPUTER, BLOOD-PRESSURE
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between -30 and 70 Degrees Celsius
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 8.9" x 10.4" x 8.75"
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Device Status

In Commercial Distribution
June 19, 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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