Tapcath

Basic Information

• Brand Name: Tapcath
• Primary DI: 00856233005059
• Version / Model: 1600, single pack
• Catalog Number: 1600
• Company Name: CARDIOCOMMAND, INC.
• Labeler DUNS: 800214827
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: bce3bb23-eb45-405e-b766-312b01bf5a70

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	870.1220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41474	Transoesophageal pacing lead	A flexible wire with an electrode, insulated with non-conductive material except at its ends, that serves as an electrical conductor to regulate cardiac pacing, with one end connected to an external temporary pacemaker and the other end (electrode) applied through the oesophagus to the heart. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856233005059	GS1
Package	10856233005056	GS1	Box of 5 units	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K905831	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	6	French