ZOLL ELECTRODE

GUDID 00847946026691

CPR UNI-PADZ III

BIO-DETEK INCORPORATED

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 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 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: 00847946026691
• NIH Device Record Key: bd590cb0-c23f-4456-ba37-7ab1fecb27ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOLL ELECTRODE
• Version Model Number: 8900-000280
• Company DUNS: 144116225
• Company Name: BIO-DETEK INCORPORATED
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 0 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 0
• Handling Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847946026691 [Primary]

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: 2020-03-24
• Device Publish Date: 2020-03-16

On-Brand Devices [ZOLL ELECTRODE]

• 00847946027179: CRP UNI-PADZ III, U.S.
• 00847946026691: CPR UNI-PADZ III