PTS Portable Calibration System

GUDID M995922006501

The Delfi PTS Portable Calibration System is a battery-powered pressure source pneumatically connected to a pressure regulator, calibrated pressure gauge, and pneumatic port. The regulator can be adjusted to allow the pressure source to deliver up to 750 mmHg of pressure through the pneumatic port to PTS instruments using the included pneumatic hoses. A power adaptor is included to recharge the battery and the Portable Calibration System is housed inside a rugged carrying case that can be closed for easy and safe transport.

Delfi Medical Innovations Inc

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

• Primary Device ID: M995922006501
• NIH Device Record Key: 0ee4ebfd-d394-4f2b-8d55-b0ce73d1de8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PTS Portable Calibration System
• Version Model Number: 9-2200-650
• 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: false
• 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	M995922006501 [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

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• M995601000234001 - Calibration Hose Set: 2023-06-02 Calibration Hose set for the use with PTS ii Portable Tourniquet System, REF: 60-1000-101-00
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• 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)