AccessGUDID - DEVICE: Pacel™ (05414734001045)

GUDID

Device Identifier (DI) Information

Brand Name: Pacel™
Version or Model: 401762
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 401762
Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Primary DI Number: 05414734001045
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040960379 *Terms of Use

Device Description: Flow Directed Pacing 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool, dark, dry place. Keep dry and keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 5 French

Device Record Status

Public Device Record Key: 840284e4-a19a-4890-b2db-c0a14255dbb2
Public Version Date: November 03, 2023
Public Version Number: 5
DI Record Publish Date: January 28, 2016