SBG MIR910510-1R

GUDID B279MIR9105101R1

Spirometer

S D I DIAGNOSTICS INC

Diagnostic spirometer

• Primary Device ID: B279MIR9105101R1
• NIH Device Record Key: 8137dc93-1a79-4161-9358-c6f7655d14db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SBG
• Version Model Number: R
• Catalog Number: MIR910510-1R
• Company DUNS: 037690120
• Company Name: S D I DIAGNOSTICS INC
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	B279MIR9105101R1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983909

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-11

Devices Manufactured by S D I DIAGNOSTICS INC

• B279F037005001 - Air Tube: 2024-04-16 Mouthpiece
• B279F037020002 - Air Tube: 2024-04-16 Mouthpiece
• B279F066105001 - Pulmoguard: 2024-04-16 Pulmoguard A Filter with Air Tube Kit
• B279S29330105001 - Pulmoguard: 2024-04-16 Pulmoguard A and Air Tube Kit
• B279S29807005001 - Air Tube: 2024-04-16 Mouthpiece
• B279S29807020002 - Air Tube: 2024-04-16 Mouthpiece
• B279F060930002 - Pulmoguard: 2024-03-21 Pulmonary function bacterial filter
• F0660200 - Pulmoguard: 2024-03-21 Pulmonary Function Bacterial Filter