Tapcath 1600

GUDID 00856233005059

6 French esophageal octapolar recording catheter, (single unit package).

CARDIOCOMMAND, INC.

Transoesophageal pacing lead

• Primary Device ID: 00856233005059
• NIH Device Record Key: bce3bb23-eb45-405e-b766-312b01bf5a70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tapcath
• Version Model Number: 1600, single pack
• Catalog Number: 1600
• Company DUNS: 800214827
• Company Name: CARDIOCOMMAND, INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 231-6370
• Email: cconley@CardioCommand.com

Device Dimensions

• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856233005059 [Primary]
GS1	10856233005056 [Package]; Package: Box of 5 units [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905831

FDA Product Code

• DRF: Catheter, Electrode Recording, Or Probe, Electrode Recording

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-22

On-Brand Devices [Tapcath]

• 00856233005059: 6 French esophageal octapolar recording catheter, (single unit package).
• 00856233005042: 5 French esophageal bipolar pacing and recording catheter, (single unit package).