De Soutter Medical

Basic Information

• Brand Name: De Soutter Medical
• Primary DI: 05051471099050
• Version / Model: T10-102
• Catalog Number: T10-102
• Company Name: DE SOUTTER MEDICAL LIMITED
• Labeler DUNS: 458064144
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-17
• Public Version: 4
• Public Version Date: 2024-01-22
• Public Version Status: Update
• Public Device Record Key: 23d471e9-b18e-4c0b-8020-33211508a670
• Distribution End Date: 2023-03-01

Device Description

IRRIGATION KIT - HST

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: 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
FQH	Lavage, Jet	General Hospital	880.5475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44772	Cardiac ablation system irrigation tubing set	A collection of sterile flexible tubing and associated items that may include clamps, filters, and connectors, used with an irrigation pump to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. The tubing is made of synthetic material and is of a fixed diameter that is specific to the requirements of the pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051471099050	GS1
Package	15051471099057	GS1	Box	5	Not in Commercial Distribution	2023-03-01