Safire™ TX

Basic Information

• Brand Name: Safire™ TX
• Primary DI: 05414734300254
• Version / Model: 402578
• Catalog Number: 402578
• Company Name: IRVINE BIOMEDICAL, INC.
• Labeler DUNS: 926346966
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-29
• Public Version: 4
• Public Version Date: 2023-02-21
• Public Version Status: Update
• Public Device Record Key: 5b092532-e00a-4b28-bbed-bbde10e81938

Device Description

Catheter Extension Cable IBI Generator 1642

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: 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
OAD	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46429	Electrical-only medical device connection cable, reprocessed	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a single-use device previously used that has been reprocessed for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414734300254	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P040042	009
P040042	052

Device Sizes

Type	Value	Unit	Text
Length	2.5	Meter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place.