DEVICE: X SERIES (04560233592995)

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Device Identifier (DI) Information

X SERIES
610-0121001-36

Zoll Medical Corporation
04560233592995
GS1
1
Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NIBP, NIBP-MOD-G, SPO2, CPR EXPANSION PACK AND ETCO2, JAPAN
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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
Rechargeable professional automated external defibrillator A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. The device is intended to be operated by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes internal rechargeable batteries that must be charged when not in use.
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FDA Product Code

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Product Code Product Code Name
MKJ Automated external defibrillators (non-wearable)
DSK COMPUTER, BLOOD-PRESSURE
CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
DQA Oximeter
DRT MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
DRO PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
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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 Atmospheric Pressure: more than 0 KiloPascal
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Temperature: between -30 and 70 Degrees Celsius
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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
January 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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