Cardio Clear LTA202

GUDID 10814907020026

RadioTranslucent Defibrillation Electrodes, Anderson Connector, Leads Out

CARDIO-MEDICAL PRODUCTS, INC.

External defibrillator electrode, adult, single-use External defibrillator electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use External defibrillation electrode, adult, single-use

• Primary Device ID: 10814907020026
• NIH Device Record Key: 1629b598-654b-430b-8ef3-df62271cf178
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardio Clear
• Version Model Number: LTA202
• Catalog Number: LTA202
• Company DUNS: 029286150
• Company Name: CARDIO-MEDICAL PRODUCTS, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com
• Phone: 9735869500
• Email: info@cardiomedicalproducts.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814907020029 [Primary]
GS1	10814907020026 [Package]; Contains: 00814907020029; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103334

FDA Product Code

• LDD: Dc-Defibrillator, Low-Energy, (Including Paddles)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-28

On-Brand Devices [Cardio Clear]

• 10814907020323: Radiotranslucent Pediatric Defibrillation Electrodes, Zoll Connector
• 10814907020316: RadioTransparent Defibrillation Electrodes, Zoll Connector, Leads Out
• 10814907020309: Radiotranslucent Defibrillation Electrodes, Zoll Connector
• 10814907020293: RadioTransparent Defibrillation Electrodes, Zoll Connector, Leads Out, Short Cord
• 10814907020286: RadioTransparent Defibrillation Electrodes, Zoll Connector, Leads Out
• 10814907020279: RadioTransparent Defibrillation Electrodes, Zoll Connector
• 10814907020262: RadioTransparent Defibrillation Electrodes, Zoll Connector
• 10814907020255: Radiotranslucent Pediatric Defibrillation Electrodes, Philips Plug Connector
• 10814907020248: RadioTransparent Defibrillation Electrodes, Philips Plug Connector, Leads Out
• 10814907020231: Radiotranslucent Defibrillation Electrodes, Philips Plug Connector, Leads Out
• 10814907020224: Radiotranslucent Defibrillation Electrodes, Philips Plug Connector
• 10814907020217: RadioTransparent Defibrillation Electrodes, Philips Plug Connector
• 10814907020200: RadioTransparent Defibrillation Electrodes, Philips Plug Connector
• 10814907020194: Radiotranslucent Pediatric Defibrillation Electrodes, Physio Connector
• 10814907020187: RadioTransparent Defibrillation Electrodes, Physio-Control Connector, Leads Out
• 10814907020170: Radiotranslucent Defibrillation Electrodes, Physio-Control Connector, Leads Out
• 10814907020163: Radiotranslucent Defibrillation Electrodes, Physio-Control Connector
• 10814907020156: RadioTransparent Defibrillation Electrodes, Physio-Control Connector
• 10814907020149: RadioTransparent Defibrillation Electrodes, Physio-Control Connector, Short Cord
• 10814907020132: RadioTransparent Defibrillation Electrodes, Physio-Control Connector
• 10814907020125: Radiotranslucent Pediatric Defibrillation Electrodes, Philips Barrel Connector
• 10814907020118: RadioTransparent Defibrillation Electrodes, Philips Barrel Connector, Leads Out
• 10814907020101: RadioTranslucent Defibrillation Electrodes, Zoll Connector, Leads Out
• 10814907020095: Radiotranslucent Defibrillation Electrodes, Philips Barrel Connector, Leads Out
• 20814907020085: Radiotranslucent Defibrillation Electrodes, Philips Barrel Connector
• 10814907020071: RadioTransparent Defibrillation Electrodes, Anderson Connector
• 10814907020064: RadioTransparent Defibrillation Electrodes, Philips Plug Connector
• 10814907020057: RadioTransparent Defibrillation Electrodes, Philips Barrel Connector
• 10814907020040: Radiotranslucent Pediatric Defibrillation Electrodes, Anderson Connector
• 10814907020033: RadioTransparent Defibrillation Electrodes, Anderson Connector, Leads Out
• 10814907020026: RadioTranslucent Defibrillation Electrodes, Anderson Connector, Leads Out
• 00814907020012: RadioTranslucent Defibrillation Electrodes, Anderson Connector
• 00814907020005: RadioTransparent Defibrillation Electrodes, Anderson Connector