Filtrette F0320-200

GUDID B279F0320200

bacterial filter

S D I DIAGNOSTICS INC

Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece

• Primary Device ID: B279F0320200
• NIH Device Record Key: 01688154-3332-41b1-9676-654a57d6c4fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Filtrette
• Version Model Number: Filtrette
• Catalog Number: F0320-200
• Company DUNS: 037690120
• Company Name: S D I DIAGNOSTICS INC
• Device Count: 200
• 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	B279F0320200 [Primary]
HIBCC	B279F3202002 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062913

FDA Product Code

• BZG: Spirometer, Diagnostic

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: 2019-03-26
• Device Publish Date: 2019-03-18

On-Brand Devices [Filtrette]

• B279S297910200: bacterial filter
• B279S297910050: bacterial filter
• B279F0320200: bacterial filter
• B279F0320050: bacterial filter