TrueOne 2400

GUDID B687MMS240005

The TrueOne® 2400 is a compact, integrated metabolic measurement system for cardiopulmonary stress testing, indirect calorimetry, and maximal O2 consu

PARVOMEDICS, INCORPORATED

Diagnostic spirometer

• Primary Device ID: B687MMS240005
• NIH Device Record Key: 44d1a8c9-352a-49b0-9439-7086358b3269
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrueOne 2400
• Version Model Number: MMS-2400
• Company DUNS: 043063893
• Company Name: PARVOMEDICS, INCORPORATED
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B687MMS240005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941843

FDA Product Code

• BZC: Calculator, Pulmonary Function Data

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: 2018-10-08
• Device Publish Date: 2018-09-06