AccessGUDID - DEVICE: Tapcath (00856233005042)

GUDID

Device Identifier (DI) Information

Brand Name: Tapcath
Version or Model: 205, single pack
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 180
Company Name: CARDIOCOMMAND, INC.

Primary DI Number: 00856233005042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800214827 *Terms of Use

Device Description: 5 French esophageal bipolar pacing and recording catheter, (single unit package).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P860008	017
P860008	019
P860008	020

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 5 French

Device Record Status

Public Device Record Key: c16b34f4-8e7a-458b-85d3-dd3823b52f58
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 03, 2015