tF Calibrated Reference Load 15cmH2O (2 Years Edition)

GUDID 07540261020698

2 year valid Reference Load (15 cm H2O.s/L) to verify tremoflo Airwave Oscillometry System calibration.

Thorasys Thoracic Medical Systems Inc

Pulmonary function analysis system, adult

• Primary Device ID: 07540261020698
• NIH Device Record Key: 4d6f9699-1617-4199-8efa-8d8e0877fb75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: tF Calibrated Reference Load 15cmH2O (2 Years Edition)
• Version Model Number: 102069
• Company DUNS: 257777701
• Company Name: Thorasys Thoracic Medical Systems Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com
• Phone: +1-514-384-8555
• Email: tabitha.jaramillo@thorasys.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540261020698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170185

FDA Product Code

• PNV: Impedance Measuring Device Utilizing Oscillation Techniques

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: 2024-09-30
• Device Publish Date: 2024-09-20

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