Cardio EP LED Headlight CMP-SSL-8500

GUDID 00814907020616

LED Battery Powered Headlight

CARDIO-MEDICAL PRODUCTS, INC.

Head-worn lamp Head-worn lamp

• Primary Device ID: 00814907020616
• NIH Device Record Key: a7afc88e-a95b-412c-87f2-6bbb1f4e2ced
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardio EP LED Headlight
• Version Model Number: 1
• Catalog Number: CMP-SSL-8500
• Company DUNS: 029286150
• Company Name: CARDIO-MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: (973) 586-9500
• Email: info@cardiomedicalproducts.com
• Phone: (973) 586-9500
• Email: info@cardiomedicalproducts.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814907020616 [Primary]

FDA Product Code

• HPP: Headlamp, Operating, Battery-Operated

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: 2019-02-07
• Device Publish Date: 2016-07-12

Devices Manufactured by CARDIO-MEDICAL PRODUCTS, INC.

• 00814907020616 - Cardio EP LED Headlight: 2019-02-07LED Battery Powered Headlight
• 00814907020616 - Cardio EP LED Headlight: 2019-02-07 LED Battery Powered Headlight
• 00814907020005 - Cardio Clear: 2018-07-06 RadioTransparent Defibrillation Electrodes, Anderson Connector
• 00814907020012 - Cardio Clear: 2018-07-06 RadioTranslucent Defibrillation Electrodes, Anderson Connector
• 10814907020026 - Cardio Clear: 2018-07-06 RadioTranslucent Defibrillation Electrodes, Anderson Connector, Leads Out
• 10814907020033 - Cardio Clear: 2018-07-06 RadioTransparent Defibrillation Electrodes, Anderson Connector, Leads Out
• 10814907020040 - Cardio Clear: 2018-07-06 Radiotranslucent Pediatric Defibrillation Electrodes, Anderson Connector
• 10814907020057 - Cardio Clear: 2018-07-06 RadioTransparent Defibrillation Electrodes, Philips Barrel Connector
• 10814907020064 - Cardio Clear: 2018-07-06 RadioTransparent Defibrillation Electrodes, Philips Plug Connector