AccessGUDID - DEVICE: Tempo Temporary Pacing Lead, Curved (10866899000210)

GUDID

Device Identifier (DI) Information

Brand Name: Tempo Temporary Pacing Lead, Curved
Version or Model: TC1106
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TC1106
Company Name: BIO TRACE MEDICAL

Primary DI Number: 10866899000210
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044674446 *Terms of Use

Device Description: The BioTrace Medical Tempo Temporary Pacing Lead is designed for temporary intracardia pacing. The lead provides access to the right ventricle via either the femoral vein, subclavian vein or the internal jugular vein approach and may be shaped near the distal end to facilitate delivery. It is a radiopaque, polymeric lead featuring a balloon , active fixations, bipolar electrodes and a soft tip.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
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?
35854	Temporary cardiac pacing balloon catheter	A sterile, flexible, balloon-tipped, tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker that generates the electrical pacing impulses. It may be unipolar or bipolar and facilitate the display of electrocardiographic signals. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDF	Electrode, Pacemaker, Temporary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160260	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 32 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 110 Centimeter
Catheter Gauge: 6 French

Device Record Status

Public Device Record Key: 7d1df49f-4154-4428-90be-f4591e05bdeb
Public Version Date: July 16, 2018
Public Version Number: 1
DI Record Publish Date: June 15, 2018