Bipolar 5FR 110cm Modified-J Shrouded Pins

Basic Information

• Brand Name: Bipolar 5FR 110cm Modified-J Shrouded Pins
• Primary DI: M8226521110P0
• Version / Model: 652/1-110P
• Catalog Number: 625/1-110P
• Company Name: ALPHA MEDICAL INSTRUMENTS
• Labeler DUNS: 627767577
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f0c72925-79f1-49ff-9665-f1bc8933e450

Device Description

Bipolar Balloon Pacing Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	870.3680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M8226521110P0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K930069	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 77 Degrees Fahrenheit