HeartSpan®

Basic Information

• Brand Name: HeartSpan®
• Primary DI: 00884450266243
• Version / Model: 00884450266243
• Catalog Number: FND-020-06
• Company Name: Merit Medical
• Labeler DUNS: 065673912
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-22
• Public Version: 3
• Public Version Date: 2020-08-20
• Public Version Status: Update
• Public Device Record Key: 575e5a77-271e-4a59-8137-506ffd8f2e80

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
DRC	Trocar	Cardiovascular	870.1390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47248	Cardiac transseptal needle, single-use	A device designed to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access typically to facilitate fluid aspiration and injection/infusion, blood sampling, and pressure monitoring. It is typically a long, thin stainless steel tube that is curved and pointed at the distal end, usually having a hub with a stopcock and orientation indicators at the proximal end. It may include a stylet for support during handling. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884450266243	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Tip Gauge-21G
Device Size Text, specify			Length (cm)-98 cm
Device Size Text, specify			Curve Angle-86°
Device Size Text, specify			Gauge-18G