AtriAmp

GUDID 10860004773709

AtriAmp

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: 10860004773709
• NIH Device Record Key: 417c3b9c-a845-40f2-b347-825b9f8a1cb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtriAmp
• Version Model Number: 10001
• 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	00860004773702 [Primary]
GS1	10860004773709 [Package]; Contains: 00860004773702; Package: Carton [5 Units]; In Commercial Distribution
GS1	20860004773706 [Package]; 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

[10860004773709]

Radiation Sterilization

[10860004773709]

Radiation Sterilization

[10860004773709]

Radiation Sterilization

[10860004773709]

Radiation Sterilization

[10860004773709]

Radiation Sterilization

[10860004773709]

Radiation Sterilization

[10860004773709]

Radiation Sterilization

[10860004773709]

Radiation Sterilization

[10860004773709]

Radiation Sterilization

[10860004773709]

Radiation Sterilization

[10860004773709]

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

Devices Manufactured by Atrility Medical LLC

• 10860004773709 - AtriAmp: 2021-01-11AtriAmp
• 10860004773709 - AtriAmp: 2021-01-11 AtriAmp
• 10860004773716 - AtriAmp - Pacing Cable: 2021-01-11 Pacing Cable, 6FT, Medtronic® Connector
• 00860004773726 - AtriAmp - Pacing Cable: 2021-01-11 Pacing Cable, 6FT, 2mm Shrouded Connector