PTS for BFR Tourniquet System & Cuff Set

GUDID M99592200200BFR3

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.

Delfi Medical Innovations Inc

Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system Surgical pneumatic tourniquet system

• Primary Device ID: M99592200200BFR3
• NIH Device Record Key: 146ba178-587a-43db-9daf-0f8f1e8bf869
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTS for BFR Tourniquet System & Cuff Set
• Version Model Number: 9-2200-200BFR
• Company DUNS: 251078945
• Company Name: Delfi Medical Innovations Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +16047420600
• Email: info@delfimedical.com
• Phone: +16047420600
• Email: info@delfimedical.com
• Phone: +16047420600
• Email: info@delfimedical.com
• Phone: +16047420600
• Email: info@delfimedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M99592200200BFR3 [Primary]

FDA Product Code

• KCY: Tourniquet, Pneumatic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

Devices Manufactured by Delfi Medical Innovations Inc

• M995979500181 - Matching Limb Protection Sleeves - Easi-Fit BFR: 2024-02-05 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing o
• M995979500241 - Matching Limb Protection Sleeves - Easi-Fit BFR: 2024-02-05 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing o
• M995979500341 - Matching Limb Protection Sleeves - Easi-Fit BFR: 2024-02-05 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing o
• M995979500441 - Matching Limb Protection Sleeves - Easi-Fit BFR: 2024-02-05 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing o
• M995601000212001 - PTS Hose Set: 2023-06-02 Hose set for use with PTS ii Portable Tourniquet System, REF: 60-1000-101-00
• M995601000234001 - Calibration Hose Set: 2023-06-02 Calibration Hose set for the use with PTS ii Portable Tourniquet System, REF: 60-1000-101-00
• M995922000243 - PTS Hose Set - Single (Female Connector): 2023-06-02 PTS Hose Set (Female metal connector) for use with Personalized Tourniquet System (PTS) for Blood Flow Restriction (BFR)
• M995922000253 - PTS Hose Set - Single (Male Connector): 2023-06-02 PTS Hose Set (Male metal connector) for use with Personalized Tourniquet System (PTS) for Blood Flow Restriction (BFR)