PTSii Personalized Tourniquet System for Blood flow Restriction (BFR)

Basic Information

• Brand Name: PTSii Personalized Tourniquet System for Blood flow Restriction (BFR)
• Primary DI: M99592200001BFR1
• Version / Model: 9-2200-001BFR
• Company Name: Delfi Medical Innovations Inc
• Labeler DUNS: 251078945
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-19
• Public Version: 1
• Public Version Date: 2023-01-27
• Public Version Status: New
• Public Device Record Key: bc0b7d4b-c68a-4a99-8830-9850be5bf472

Device Description

The Delfi PTS ii Portable Tourniquet System is intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	878.5910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14074	Surgical pneumatic tourniquet system	A device assembly intended to occlude the blood flow and to obtain a bloodless field during limb surgery or amputation. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to inflate the cuff, and a control unit, i.e., a pressure indicator and regulator. By using a double cuff and a manual switching or automatic valve, the pressure point is regularly changed to avoid tissue damage or necrosis. The device will also typically include a timer or elapsed-time meter. It may also be used in combination with intravenous local anaesthesia to limit the area affected by the anaesthesia.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M99592200001BFR1	HIBCC

Customer Contacts

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