FloSense II DP300-100

GUDID B279DP300100

FloSense II Sensor

S D I DIAGNOSTICS INC

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• Primary Device ID: B279DP300100
• NIH Device Record Key: 2bdd5a23-d811-4d76-8cde-b0bef37efc87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloSense II
• Version Model Number: FloSense II
• Catalog Number: DP300-100
• Company DUNS: 037690120
• Company Name: S D I DIAGNOSTICS INC
• Device Count: 100
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	B279DP300100 [Primary]
HIBCC	DP3001002 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033939

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-23
• Device Publish Date: 2016-09-09

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• B279DP311200: FloSense II
• B279DP301250: FloSense II Sensor
• B279DP301100: FloSense II Sensor
• DP301200: FloSense II Sensor
• B279DP300250: FloSense II Sensor
• B279DP300100: FloSense II Sensor
• B279DP300200: FloSense II Sensor
• B279298040K250: FloSense II
• B279298040K100: FloSense II
• B279298040200: FloSense II
• B279298040F250: FloSense II
• B279298040F100: FloSense II
• B279298040F050: FloSense II