FloSense II DP301-050

GUDID DP301200

FloSense II Sensor

S D I DIAGNOSTICS INC

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• Primary Device ID: DP301200
• NIH Device Record Key: 583bd156-351f-4444-b744-1b324ba59ff4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloSense II
• Version Model Number: FloSense II klip
• Catalog Number: DP301-050
• Company DUNS: 037690120
• Company Name: S D I DIAGNOSTICS INC
• Device Count: 50
• 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: false
• 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	B279DP301050 [Primary]
HIBCC	DP3010501 [Unit of Use]
HIBCC	DP301200 [Package]; Contains: B279DP301050; Package: case [50 Units]; In Commercial Distribution

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

On-Brand Devices [FloSense II ]

• B279S298040250: FloSense II
• B279S298040100: FloSense II
• B279S298040200: FloSense II
• B279DP311250: FloSense II
• B279DP311100: FloSense II
• 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