Mouthpiece DP410-025

GUDID B279DP410100

Mouthpiece

S D I DIAGNOSTICS INC

Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable Breathing mouthpiece, reusable

• Primary Device ID: B279DP410100
• NIH Device Record Key: c47a08ab-8847-40a1-af99-b16f2b872bd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mouthpiece
• Version Model Number: Sense
• Catalog Number: DP410-025
• Company DUNS: 037690120
• Company Name: S D I DIAGNOSTICS INC
• Device Count: 25
• 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: false
• 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	B279DP410025 [Primary]
HIBCC	B279DP410100 [Package]; Contains: B279DP410025; Package: case [25 Units]; In Commercial Distribution
HIBCC	B27DP4100251 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150515

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: 2020-02-24
• Device Publish Date: 2016-09-20

On-Brand Devices [Mouthpiece]

• B279S298050300: Mouthpiece
• B279S298050025: Mouthpiece
• B279DP410100: Mouthpiece
• B279DP400300: Mouthpiece
• B279DP400100: Mouthpiece
• B279298050K100: Mouthpiece
• B279S2980602002: Accurette
• B279S2980600501: Accurette
• B279S2970701: oval
• B279M70701: oval
• B279F03602002: Accurette
• B279F03600501: Accurette