AccessGUDID - DEVICE: Tapsystem (00856233005073)

GUDID

Device Identifier (DI) Information

Brand Name: Tapsystem
Version or Model: 2A Patient Cable
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2010
Company Name: CARDIOCOMMAND, INC.

Primary DI Number: 00856233005073
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 800214827 *Terms of Use

Device Description: A cable used to connect a patient to a Model 2A pulse generator system for the treatment of cardiac dysrhythmias.

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:	No
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?
44862	Temporary cardiac pacing/stimulation connection cable, reusable	A flexible wire, insulated with non-conductive material except at its ends, that provides a connection between an external temporary pacemaker and implanted cardiac pacing leads, to transmit electrical impulses to the heart and possibly relay information about the heart's activity back to the pacemaker. The proximal end plugs into a temporary pacemaker or an adaptor (e.g., when the cable/lead does not meet original design), and the distal end, which may consist of a connector block to accommodate different connection configurations, connects to the pacing leads/heart wires (e.g., IS-1 leads). This is a reusable device intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LPA	System, Esophageal Pacing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P840002	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 1956b9de-05bb-4a4e-85be-3b73141bbe92
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 22, 2015