PTSii Personalized Tourniquet System (Red)

GUDID M99592200001R1

The 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

• Primary Device ID: M99592200001R1
• NIH Device Record Key: be856d80-c889-4bdf-8d57-cf7e23c2293d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTSii Personalized Tourniquet System (Red)
• Version Model Number: 9-2200-001_R
• 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: false
• 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	M99592200001R1 [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)