AtriAmp - Pacing Cable

GUDID 00860004773726

Pacing Cable, 6FT, 2mm Shrouded Connector

Atrility Medical LLC

Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use Electrical-only medical device connection cable, single-use

• Primary Device ID: 00860004773726
• NIH Device Record Key: d6fbe831-3ba1-47cb-838d-be9d3be863b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtriAmp - Pacing Cable
• Version Model Number: 10052
• Company DUNS: 080558780
• Company Name: Atrility Medical LLC
• 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: true
• Expiration Date: true
• 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
GS1	00860004773726 [Primary]
GS1	10860004773723 [Package]; Package: Carton [5 Units]; In Commercial Distribution
GS1	20860004773720 [Package]; Contains: 10860004773723; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200674

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

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

[00860004773726]

Radiation Sterilization

[00860004773726]

Radiation Sterilization

[00860004773726]

Radiation Sterilization

[00860004773726]

Radiation Sterilization

[00860004773726]

Radiation Sterilization

[00860004773726]

Radiation Sterilization

[00860004773726]

Radiation Sterilization

[00860004773726]

Radiation Sterilization

[00860004773726]

Radiation Sterilization

[00860004773726]

Radiation Sterilization

[00860004773726]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-11
• Device Publish Date: 2021-01-01

On-Brand Devices [AtriAmp - Pacing Cable]

• 00860004773726: Pacing Cable, 6FT, 2mm Shrouded Connector
• 10860004773716: Pacing Cable, 6FT, Medtronic® Connector