FloSense 29-8010

GUDID B279S298011

Pneumotachometer

S D I DIAGNOSTICS INC

Pulmonary function analysis system, adult

• Primary Device ID: B279S298011
• NIH Device Record Key: 7a1e7170-6a61-4992-b0c3-9ad69e6a55e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloSense
• Version Model Number: FloSense
• Catalog Number: 29-8010
• 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: 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	B279S298010 [Primary]
HIBCC	B279S298011 [Package]; Contains: B279S298010; Package: case [50 Units]; In Commercial Distribution
HIBCC	S2980101 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990962

FDA Product Code

• JAX: Pneumotachometer

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: 2018-07-06
• Device Publish Date: 2016-07-26

On-Brand Devices [FloSense]

• B279S298021: Pneumotachometer
• B279S298020: Pneumotachometer
• B279S298012: Pneumotachometer
• B279S298011: Pneumotachometer
• B279DP2527: Bidirectional kushion klip
• B279DP2524: FloSense Sensor
• B279DP2517: FloSense Sensor
• B279DP2514: FloSense Sensor
• B279DP2507: FloSense Sensor
• B279DP2504: FloSense Sensor
• B279DP2112: FloSense Sensor
• DP2110: FloSense Sensor
• B279DP2012: FloSense Sensor
• B279DP2010: FloSense Sensor
• B279DP2002: FloSense Sensor
• B279DP2000: FloSense Sensor
• B279298021K1: Pneumotachometer
• B279298021F1: Pneumotachometer
• B279298020K1: Pneumotachometer
• B279298020F1: Pneumotachometer
• B279298012K1: Pneumotachometer
• B279298012F1: Pneumotachometer
• B279298011K: Pneumotachometer
• B279298011F: Pneumotachometer