ResQGARD FM Kit

GUDID M5921207070000

The ResQGARD ITD 7 is indicated for the temporary increase in blood circulation. The device is used to enhance circulation by lowering intrathoracic pressure in spontaneously breathing patients who experience poor circulation and low blood flow that may be indicated by low blood pressure. The device functions by adding selective inspiratory airway impedance within the respiratory circuit. Airway impedance is experienced when the patient spontaneously inspires. Expiratory impedance is negligible.

ADVANCED CIRCULATORY SYSTEMS INC

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• Primary Device ID: M5921207070000
• NIH Device Record Key: 382a91f4-10e5-42f9-a740-53b2c57c10e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ResQGARD FM Kit
• Version Model Number: 12-0707-000
• Company DUNS: 140320396
• Company Name: ADVANCED CIRCULATORY SYSTEMS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M5921207070000 [Primary]

FDA Product Code

• BWF: Spirometer, Therapeutic (Incentive)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-04-03
• Device Publish Date: 2018-08-23