Premier Heart Reusable Limb Clip Electrodes

GUDID B320LCA10

Reusable Limb Clip Electrodes, Large, US/AHA Lead Colors

PREMIER HEART, LLC

Electrocardiographic electrode, reusable

• Primary Device ID: B320LCA10
• NIH Device Record Key: 16cd37ec-9fc2-4844-82fd-8f5dd485725b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier Heart Reusable Limb Clip Electrodes
• Version Model Number: LCA1
• Company DUNS: 109797584
• Company Name: PREMIER HEART, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B320LCA10 [Primary]

FDA Product Code

• DRX: Electrode, Electrocardiograph

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: 2024-05-14
• Device Publish Date: 2024-05-06

On-Brand Devices [Premier Heart Reusable Limb Clip Electrodes]

• B320LCA20: Reusable Limb Clip Electrodes, Large, EU/IEC Lead Colors
• B320LCA10: Reusable Limb Clip Electrodes, Large, US/AHA Lead Colors
• B320LCA00: Reusable Limb Clip Electrodes, Large, Universal Lead Colors