N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10841898129759
• Version / Model: N/A
• Catalog Number: 407200
• Company Name: INNOVATIVE HEALTH LLC
• Labeler DUNS: 015575953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-26
• Public Version: 1
• Public Version Date: 2020-09-03
• Public Version Status: New
• Public Device Record Key: 0e1e07e2-0b9d-4e25-9a51-ebd171c6d1e0

Device Description

Reprocessed BRK 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
NMK	Trocar, Reprocessed	Cardiovascular	870.1390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65040	Cardiac transseptal needle, reprocessed	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 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	10841898129759	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192998	000