IntellaTip MiFi™ Filter Module

Basic Information

• Brand Name: IntellaTip MiFi™ Filter Module
• Primary DI: 08714729854395
• Version / Model: M0041212H0
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Labeler DUNS: 021717889
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-08
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: faaaab0c-8077-407b-ae05-5d00a8f26b66

Device Description

RF Frequency Filter

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
36806	Electronic signal frequency filter	An electronic filter that transfers electronic signals at all frequencies within a certain area, and suppresses signals at all other frequencies outside this area. This GMDN code also includes octave and third-octave filters.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08714729854395	GS1

Premarket Submissions

Submission Number	Supplement Number
P020025	036
P020025	045
P020025	046
P020025	059
P020025	060
P020025	061
P020025	074
P020025	075