AED PLUS

GUDID 00847946099428

Defibrillator ,MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, JAPANESE

Zoll Medical Corporation

Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator Rechargeable professional automated external defibrillator

• Primary Device ID: 00847946099428
• NIH Device Record Key: 9e7944c8-a676-4259-8c62-73798270277b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED PLUS
• Version Model Number: 20000000100011360
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946099428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120406

FDA Product Code

• MKJ: Automated external defibrillators (non-wearable)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-24
• Device Publish Date: 2020-09-16

On-Brand Devices [AED PLUS]

• 00847946099381: Defibrillator ,MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, SPANISH, US
• 00847946024475: MAIN ASSY, PS SERIES, ECG ON, LCD, NO VOICE RCDG, ENGLISH, REFURB
• 00847946024468: MAIN ASSY, AED PLUS, PA SERIES, NO GRAPHICS, W/BASIC CVR, NO LCD, NO VOICE RCDG, NO CPR, ENG, RE
• 00847946024291: Defibrillator ,MAIN ASSY, PS SERIES, FULLY AUTOMATIC, LCD, NO VOICE RCDG, AHA SPANISH
• 00847946024239: MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, 50HZ, SPANISH
• 00847946024222: MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, 60HZ, FRENCH
• 00847946023782: ASSY,AED PLUS BATTERY PACK,AVIATION
• 00847946017088: Defibrillator ,MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, ENGLISH, AVIATION
• 00847946015138: Defibrillator ,ASSY, MAIN, SEMI AUTOMATIC ONLY, NO BATTERIES, NO ELECTRODES, AED PRO
• 00847946015121: Defibrillator ,ASSY, MAIN, SEMI AUTO/MANUAL OVERIDE, NO BATTERIES, NO ELECTRODES, AED PRO
• 00847946015114: Defibrillator ,MAIN ASSY, AED PLUS, PS SERIES, NO GRAPHICS, W/AED CVR, LCD, VOICE RCDG, ENG
• 00847946015107: Defibrillator ,MAIN ASSY, AED PLUS, PS SERIES, NO GRAPHICS, W/BASIC CVR, LCD, VOICE RCDG, ENG
• 00847946015091: Defibrillator ,MAIN ASSY, AED PLUS, PS SERIES, W/AED CVR, LCD, VOICE RCDG, ENG, REFURB
• 00847946006938: Defibrillator ,MAIN ASSY, AED PLUS, PS SERIES, W/BASIC CVR, LCD, VOICE RECORDING, ENG, REFURB
• 00847946006921: Defibrillator ,MAIN ASSY, PS SERIES, LCD, VOICE, RCDG, ENGLISH, REFURB
• 00847946006914: Defibrillator ,MAIN ASSY, PS SERIES, NO GRAPHICS, LCD, NO VOICE RCDG, ENGLISH, REFURB
• 00847946006907: Defibrillator ,MAIN ASSY, PS SERIES, W/AED CVR, LCD, NO VOICE RECORDING, ENGLISH, REFURB
• 00847946006891: Defibrillator ,MAIN ASSY, PS SERIES, W/BASIC CVR, LCD, NO VOICE RECDG, 60HZ,DMST, REFURB
• 00847946006884: Defibrillator ,MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, ENGLISH, REFURB
• 00847946006877: Defibrillator ,MAIN ASSY, AED PLUS, PA SERIES, NO LCD, NO VOICE RCDG, ENG, REFURB
• 00847946006860: Defibrillator ,MAIN ASSY, PA SERIES, NO LCD, NO VOICE RCDG, ENGLISH, REFURB
• 00847946002251: Defibrillator ,MAIN ASSY, PS SERIES, NO GRAPHICS, ECG ON, LCD, NO VOICE RCDG, ENGLISH
• 00847946002244: Defibrillator ,MAIN ASSY, PS SERIES, ECG ON, LCD, NO VOICE RCDG, ENGLISH
• 00847946002237: Defibrillator ,MAIN ASSY, PS SERIES, FULLY AUTOMATIC, LCD, NO VOICE RCDG, DMST
• 00847946002220: Defibrillator ,MAIN ASSY, PA SERIES, NO GRAPHICS, NO LCD, VOICE RCDG, ENGLISH
• 00847946002213: Defibrillator ,MAIN ASSY, PA SERIES, NO GRAPH, NO CPR,NO LCD, NO VOICE RCDG, ENGLISH
• 00847946002206: Defibrillator ,MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, ENG
• 00847946002190: Defibrillator ,MAIN ASSY, PS SERIES, NO GRAPHICS, LCD, VOICE RCDG, ENGLISH
• 00847946002183: Defibrillator ,MAIN ASSY, PS SERIES, LCD, VOICE, RCDG, ENGLISH
• 00847946002176: Defibrillator ,MAIN ASSY, PS SERIES, NO GRAPHICS, LCD, NO VOICE RCDG, ENGLISH
• 00847946002169: Defibrillator ,MAIN ASSY, PS SERIES, NO GRAPHICS, LCD, NO VOICE RCDG, ENGLISH
• 00847946002152: Defibrillator ,MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, ENGLISH
• 00847946002145: Defibrillator ,MAIN ASSY, PA SERIES, NO LCD, NO VOICE RCDG, ENGLISH
• 04560233596405: Defibrillator ,MAIN ASSY, PS SERIES, LCD, WKLY, NO VOICE RCDG, JAPANESE
• 04560233596030: Defibrillator ,MAIN ASSY, PS SERIES, LCD, VOICE, RCDG, JAPANESE
• 04560233596016: Defibrillator ,MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, JAPANESE
• 00847946027049: MAIN ASSY, PS SERIES, FULLY AUTOMATIC, LCD, NO VOICE RCDG, DMST, REFURB
• 04560233596269: Defibrillator ,MAIN ASSY, PS SERIES, LCD, WKLY, NO VOICE RCDG, JAPANESE
• 00847946099435: Defibrillator ,MAIN ASSY, PS SERIES, LCD, VOICE, RCDG, JAPANESE
• 00847946099428: Defibrillator ,MAIN ASSY, PS SERIES, LCD, NO VOICE RCDG, JAPANESE
• 00847946096533: AED PLUS, PA SERIES, NO LCD, NO VOICE RCDG, ENG, REFURB
• 00847946096243: AED PLUS, PS SERIES NO GRAPHICS, W/AED CVR, LCD, VOICE RCDG, ENG
• 00847946096229: AED PLUS, PS SERIES W/AED CVR, LCD, VOICE RCDG, ENG, REFURB
• 00847946096212: AED PLUS, PS SERIES W/BASIC CVR, LCD, VOICE RCDG, ENG, REFURB
• 00847946096199: AED PLUS, PS SERIES NO GRAPHICS, W/AED CVR, LCD, NO VOICE RCDG, ENG, REFURB
• 00847946096168: AED PLUS, PS SERIES, W/AED CVR, LCD, NO VOICE RECORDING, ENGLISH, REFURB