Cardio EP LED Headlight CMP-SSL-8500

GUDID 00814907020616

LED Battery Powered Headlight

CARDIO-MEDICAL PRODUCTS, INC.

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.

• 10814907020545 - ScatPad: 2024-09-23 SCATPAD SEPA 442 EP Multi-Purpose Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Scoop Fenestra
• 00814907020678 - ScatPad: 2024-09-23 SCATPAD STSN 802 Table Skirt Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Dual Level
• 10814907020347 - ScatPad: 2024-09-20 SCATPAD SMA 102 Multipurpose Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Multipurpose Shield
• 10814907020569 - ScatPad: 2024-09-20 SCATPAD SPA 501 Peripheral Shield, Attenuation @90k Vp > 75% (0.125mm), Scatter Radiation Drape, Absorbent, Single Level
• 10814907020576 - ScatPad: 2024-09-20 SCATPAD SPA 502 Peripheral Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Dual Level
• 10814907020590 - ScatPad: 2024-09-20 SCATPAD SDFA 701 EP Dialysis/DE-Clotting Shield, Attenuation @90k Vp > 75% (0.125mm), Scatter Radiation Drape, Absorbent, Shield
• 10814907020606 - ScatPad: 2024-09-20 SCATPAD SDFA 702 EP Dialysis/DE-Clotting Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Shield
• 10814907020620 - ScatPad: 2024-09-20 SCATPAD SEPA 402-A EP Shield, Attenuation @90k Vp > 90% (0.25mm), Scatter Radiation Drape, Absorbent, Scoop Fenestration Dual Le