Astraguard F0312-100

GUDID B279F0312100

Bacterial Viral Filter

S D I DIAGNOSTICS INC

Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use

• Primary Device ID: B279F0312100
• NIH Device Record Key: 72b39cf8-ebb9-4cb7-a8ca-18d406dee5f0
• Commercial Distribution Discontinuation: 2019-03-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Astraguard
• Version Model Number: Kushion Klip , Flotube
• Catalog Number: F0312-100
• 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: true
• 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	B279F0312100 [Primary]
HIBCC	B279F03121002 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-23
• Device Publish Date: 2016-09-13

On-Brand Devices [Astraguard]

• B279S297997300: Bacterial viral filter
• B279S297997100: Bacterial viral filter
• B279S297997200: bacterial viral filter
• B279S297996300: Bacterial viral filter
• B279S297996100: Bacterial viral filter
• B279S297996200: Bacterial Viral Filter
• B279S297995300: Bacterial viral filter
• B279S297995100: Bacterial viral filter
• B279S297995200: Bacterial Viral Filter
• B279S297994300: Bacterial viral filter
• B279S297994100: Bacterial viral filter
• B279S297994200: Bacterial Viral Filter
• B279S297993300: Bacterial viral filter
• B279S297993100: Bacterial viral filter
• B279S297993200: Bacterial viral filter
• B279S297992300: Bacterial viral filter
• B279S297992100: Bacterial viral filter
• B279S297992200: bacterial viral filter
• B279S297991300: Bacterial viral filter
• B279S297991100: Bacterial viral filter
• B279S297991200: Bacterial viral filter
• B279S297990300: Bacterial Viral Filter
• B279S297990100: Bacterial Viral Filter
• B279S297990200: Bacterial Viral Filter
• B279F0502300: Bacterial Viral Filter
• B279F0502200: Bacterial Viral Filter
• B279F0502100: Bacterial Viral Filter
• B279F0502050: Bacterial Viral Filter
• B279F0501300: Bacterial Viral Filter
• B279F0501100: Bacterial Viral Filter
• B279F0501050: Bacterial Viral Filter
• B279F0312300: Bacterial Viral Filter
• B279F0312100: Bacterial Viral Filter
• B279F0312050: Bacterial Viral Filter
• B279F0311300: Bacterial Viral Filter
• B279F0311100: Bacterial Viral Filter
• B279F0311200: Bacterial Viral Filter
• B279F0303300: Bacterial filter
• B279F0303100: Bacterial filter
• B279F0303200: Bacterial filter
• B279F0302300: Astraguard Filter
• B279F0302100: Astraguard Filter
• B279F0302200: Astraguard Filter
• B279F0301300: Astraguard Filter
• B279F0301100: Astraguard Filter
• B279F0301200: Astraguard Filter
• B279F0300300: Bacterial Viral Filter
• B279F0300100: Bacterial Viral Filter
• B279F0300050: Bacterial Viral Filter
• B279S2931071002: Bacterial Viral Filter