AccessGUDID - DEVICE: Tapscope (00856233005011)

GUDID

Device Identifier (DI) Information

Brand Name: Tapscope
Version or Model: 550F, single pack
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 250
Company Name: CARDIOCOMMAND, INC.

Primary DI Number: 00856233005011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800214827 *Terms of Use

Device Description: 18 French, Esophageal stethoscope with bipolar pacing and recording electrodes and a female temperature connector, (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?
44120	Electronic oesophageal stethoscope, single-use	An electronic listening device designed to be inserted into a patient's oesophagus to listen to heart and breathe sounds, typically while the patient is under anaesthesia. Some types may also have a temperature sensor to monitor the patient's temperature. The device will typically contain integral electrical conductors, thermistors/temperature sensors for proximal connection to a patient monitoring device, and include a proximal connector for a standard earpiece. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZT	Stethoscope, Esophageal, With Electrical Conductors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P860008	018
P860008	021

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: 18 French

Device Record Status

Public Device Record Key: 3d29f27a-247b-4dd0-bd50-6653538dcd31
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 08, 2015