TB

Basic Information

• Brand Name: TB
• Primary DI: 00885672004378
• Version / Model: TBRHK04110USG
• Catalog Number: TBRHK04110USG
• Company Name: Oscor Inc.
• Labeler DUNS: 101835833
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-27
• Public Version: 3
• Public Version Date: 2020-07-24
• Public Version Status: Update
• Public Device Record Key: 779fdab3-8298-4179-bd66-7ff2a5befda2
• Distribution End Date: 2018-08-14

Device Description

Temporary Pacing Lead Convenience Kit, 4F, Right Heart Curve Unshrouded

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• 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
47311	Atrial cardioversion system catheter	A sterile, thin, flexible tube that interfaces proximally with an electrocardiogram (ECG) monitor/recorder and defibrillator, and distally with the myocardium, for electrical cardioversion (CV) to treat atrial tachyarrhythmias [e.g., atrial fibrillation (AF)]. It typically has multiple lumens with specific functions (e.g., for various electrode arrays, guidewire, air) and may be balloon-tipped to facilitate transvenous placement; it may have sensing, pacing, and pressure measurement capabilities. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885672004378	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.4	Millimeter
Length	110	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius