Mouthpiece 29-8050K-025

GUDID B279298050K100

Mouthpiece

S D I DIAGNOSTICS INC

Breathing mouthpiece, reusable

• Primary Device ID: B279298050K100
• NIH Device Record Key: 3c8d5756-8588-4dba-ac1a-7326463993aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mouthpiece
• Version Model Number: Sense
• Catalog Number: 29-8050K-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	B279298050K025 [Primary]
HIBCC	B279298050K100 [Package]; Contains: B279298050K025; Package: case [25 Units]; In Commercial Distribution
HIBCC	B2798050K0251 [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