N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10841898130809
• Version / Model: N/A
• Catalog Number: NRG-E-HF-71-C0
• Company Name: INNOVATIVE HEALTH LLC
• Labeler DUNS: 015575953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 2
• Public Version Date: 2024-02-09
• Public Version Status: Update
• Public Device Record Key: 6be85e36-7cc4-4643-854b-14c9023cfb36

Device Description

Reprocessed NRG Transseptal Needle, 71 cm

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
QLZ	Septostomy Catheter, Reprocessed	Cardiovascular	870.5175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65069	Cardiac transseptal access electrosurgical catheter, reprocessed	A flexible tube intended to be used during a transseptal catheterization procedure to: 1) apply radio-frequency alternating current in a monopolar configuration, to puncture the interatrial septum and gain access to the left atrium; and 2) provide a fluid path to facilitate aspiration, injection/infusion, blood sampling, and/or pressure monitoring; it is not intended for cardiac ablation or to accommodate a needle in its lumen. It has a distal monopolar electrode. This is a previously used single-use device that has been processed 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	10841898130809	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K200060	000
K213584	000