AccessGUDID - DEVICE: N/A (00801741011573)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 106173P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 106173P
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741011573
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: OEM Product - Transvenous Pacing Electrodes, Bipolar Balloon Temporary Pacing Electrode Catheter

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):	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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 5 French
Length: 110 Centimeter

Device Record Status

Public Device Record Key: 936f19bd-6bc6-4c2f-861a-02eb739eb2ce
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 29, 2015