AccessGUDID - DEVICE: NBIH™ Temporary Pacing Electrode Catheter (00801741011474)

GUDID

Device Identifier (DI) Information

Brand Name: NBIH™ Temporary Pacing Electrode Catheter
Version or Model: 057152P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 057152P
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741011474
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: NBIH Temporary Pacing Electrode Catheter

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):	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?
47852	Temporary cardiac pacing catheter	A sterile, flexible 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 which generates the electrical pacing impulses. It may be unipolar or bipolar and facilitates the display of the electrocardiographic signal. 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: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 100 Centimeter
Catheter Gauge: 6 French

Device Record Status

Public Device Record Key: 0e556e7f-7a61-4f29-a569-c4eb86a0c777
Public Version Date: April 01, 2025
Public Version Number: 4
DI Record Publish Date: June 29, 2015