PROPAQ M

GUDID 00847946099602

Defibrillator ,MAIN ASSY, 12LD, SPO2, C02, NIBP, IBP, PROPAQ M, REFURB

Zoll Medical Corporation

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 00847946099602
• NIH Device Record Key: 16eabc5d-992d-4dfd-9040-4893cf6cddcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROPAQ M
• Version Model Number: 210-2221310-01-66
• Company DUNS: 055363428
• Company Name: Zoll Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946099602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102174

FDA Product Code

• DSK: COMPUTER, BLOOD-PRESSURE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2015-05-11

On-Brand Devices [PROPAQ M]

• 00847946099602: Defibrillator ,MAIN ASSY, 12LD, SPO2, C02, NIBP, IBP, PROPAQ M, REFURB
• 00847946099527: Defibrillator ,MAIN ASSY, 12LD, LTA, AED, CPR, SPO2, C02, NIBP, IBP, BLUETOOTH, 80mm PRINTER, PR
• 00847946099510: Defibrillator ,MAIN ASSY, 12LD, LTA, AED, CPR, SPO2, C02, NIBP, IBP, BLUETOOTH, PROPAQ M
• 00847946026448: Defibrillator ,MAIN ASSY, 12LD, SPO2, NELLCOR, C02, NIBP, IBP, AW, PROPAQ M
• 00847946020392: MAIN ASSY, 12LD, SPO2, SPCO, SPMET, SPOC, PVI & PI, CO2, NIBP, IBP, PROPAQ M, W/80MM PRINTER
• 00847946020378: MAIN ASSY, 12LD, SPO2, SPCO, NIBP, IBP, PROPAQ M, W/80MM PRINTER
• 00847946020361: MAIN ASSY, 12LD, SPO2, SPCO, C02, NIBP, IBP, PROPAQ M
• 00847946020354: MAIN ASSY, 12LD, SPO2, SPCO, PVI & PI, C02, NIBP, IBP, PROPAQ M
• 00847946020347: MAIN ASSY, 12LD, SPO2, SPCO, SPMET, SPHB, SPOC, PVI & PI,C02, NIBP, IBP, PROPAQ M
• 00847946020330: MAIN ASSY, 12LD, SPO2, SPCO, SPMET, NIBP, IBP, PROPAQ M, W/80MM PRINTER
• 00847946020323: MAIN ASSY, 12LD, SPO2, SPCO, SPMET, C02, NIBP, IBP, PROPAQ M
• 00847946020316: Defibrillator ,MAIN ASSY, 12LD, SPO2, SPOC, C02, NIBP, IBP, PROPAQ M
• 00847946020101: Defibrillator ,MAIN ASSY, 12LD, SPO2, C02, NIBP, IBP, PROPAQ M
• 00847946020095: Defibrillator ,MAIN ASSY, 12LD, SPO2, C02, NIBP, IBP, PROPAQ M, W/80MM PRINTER
• 00847946020026: Defibrillator ,MAIN ASSY, 12LD, SPO2, SPCO, SPMET, SPHB, SPOC, PVI, PINIBP, IBP, PROPAQ M, W/80M
• 00847946019808: Defibrillator ,MAIN ASSY, 12LD, SPO2, SPCO, PVI, PI, C02, NIBP, IBP, PROPAQ M
• 00847946019792: Defibrillator ,MAIN ASSY, 12LD, SPO2, SPCO, SPMET, SPHB, SPOC, PVI, PINIBP, IBP, PROPAQ M, W/80M
• 00847946018351: Defibrillator ,MAIN ASSY, 12LD, SPO2, SPCO, C02, NIBP, IBP, PROPAQ M
• 00847946017118: Defibrillator ,MAIN ASSY, 12LD, SPO2, SPCO, SPMET, NIBP, IBP, PROPAQ M, W/80MM PRINTER
• 00847946017101: Defibrillator ,MAIN ASSY, 12LD, SPO2, SPCO, NIBP, IBP, PROPAQ M, W/80MM PRINTER
• 00847946017095: Defibrillator ,MAIN ASSY, 12LD, SPO2, C02, NIBP, IBP, PROPAQ M, W/80MM PRINTER
• 00847946002282: Defibrillator ,MAIN ASSY, 12LD, SPO2, SPCO, SPMET, C02, NIBP, IBP, PROPAQ M
• 00847946002275: Defibrillator ,MAIN ASSY, 12LD, SPO2, SPCO, C02, NIBP, IBP, PROPAQ M
• 00847946002268: Defibrillator ,MAIN ASSY, 12LD, SPO2, C02, NIBP, IBP, PROPAQ M
• 00847946002138: Defibrillator ,MAIN ASSY, 12LD, SPO2, C02, NIBP, IBP, LTA, PROPAQ M
• 00847946002121: Defibrillator ,MAIN ASSY, 12LD, SPO2, CO2, NIBP, IBP, PROPAQ M, REFURB
• 00847946002114: Defibrillator ,MAIN ASSY, 12LD, SPO2, C02, NIBP, IBP, PROPAQ M
• 00847946026707: Defibrillator ,MAIN ASSY, 12LD, SPO2, NELLCOR, C02, NIBP, IBP, AW, PROPAQ M, REFURB
• 00847946027148: MAIN ASSY, PROPAQ M, 12LD, SPO2, C02, 3 IBP, IBP, 2 TEMP, COMMS (WIFI, BT) PRINTER
• 00847946026646: Defibrillator ,MAIN ASSY, PROPAQ M, 12LD, SPO2, SPCO, SPMET, SPHB, SPOC, PVI & PI,C02, NIBP, IBP
• 00847946026639: Defibrillator ,MAIN ASSY, PROPAQ M, MAIN ASSY, 12LD, SPO2, C02, NIBP, IBP, AW, NO PRINTER, REMOT
• 00847946029500: X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12-LEAD W/INTERP, PACE, SPO2, SPCO, SPMET, SPHB, SPOC,
• 00847946046910: X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 12-LEAD W/INTERP, PACE, SPO2, SPCO, SPMET, SPHB, SPOC,
• 00847946029401: MAIN ASSY, 12LD, SPO2, SPCO, SPMET, SPOC, PVI & PI, CO2, NIBP, IBP, PROPAQ M, W/80MM PRINTER, RE
• 00847946080488: PROPAQ M, 12LD, SPO2, SPCO, SPMET, CO2, NIBP, IBP, US MILITARY
• 00847946080464: PROPAQ M, 12LD, SPO2, SPCO, CO2, NIBP, IBP, US MILITARY
• 00847946080457: PROPAQ M, 12LD, TEMP, SPO2, CO2, NIBP, IBP, NO PRINTER, REMOTE VIEWING, US MILITARY
• 00847946080426: PROPAQ M, 12LD, SPO2, C02, NIBP, IBP, W/80MM PRINTER
• 00847946080389: PROPAQ M, 12LD, SPO2, CO2, NIBP, IBP, US MILITARY, REFURB
• 00847946080372: PROPAQ M, 12LD, SPO2, CO2, NIBP, IBP, US MILITARY
• 00847946080365: PROPAQ M, 12LD, SPO2, C02, 3 IBP, IBP, 2 TEMP, COMMS (WIFI, BT) PRINTER
• 00847946080358: PROPAQ M, 12LD, SPO2, CO2, NIBP, IBP, US MILITARY, REFURB
• 00847946080341: PROPAQ M, 12LD, SPO2, CO2, NIBP, IBP, US MILITARY
• 00847946080648: PROPAQ M, 12LD, SPO2, CO2, NIBP, IBP, FRSS US MILITARY
• 00847946080617: PROPAQ M, 12LD, TEMP, SPO2, SPCO, SPMET, SPHB, SPOC, PVI & PI,C02, NIBP, IBP, NO PRINTER, REMOTE
• 00847946080600: PROPAQ M, 12LD, SPO2, SPCO, SPMET, SPHB, SPOC, PVI & PI, CO2, NIBP, IBP, US MILITARY
• 00847946080587: PROPAQ M, 12LD, SPO2, CO2, NIBP, IBP, W/ 80MM PRINTER
• 00847946080570: PROPAQ M, 12LD, SPO2, SPC0, NIBP, IBP
• 00847946080563: PROPAQ M, 12LD, SPO2, SPCO, SPMET, SPHB, SPOC, PVI & PI, CO2, NIBP, IBP, US MILITARY, W/80MM PRI
• 00847946080532: PROPAQ M, 12LD, SPO2, NELLCOR, CO2, NIBP, IBP, US MILITARY, REFURB