Air Tube F0370-050

GUDID B279F037005001

Mouthpiece

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

• Primary Device ID: B279F037005001
• NIH Device Record Key: 741c2b3d-38fe-45cc-86dd-c25068cff8ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air Tube
• Version Model Number: AT
• Catalog Number: F0370-050
• Company DUNS: 037690120
• Company Name: S D I DIAGNOSTICS INC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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	B279F0370050 [Primary]
HIBCC	B279F037005001 [Unit of Use]

FDA Product Code

• BYP: Mouthpiece, Breathing

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: 2024-04-16
• Device Publish Date: 2024-04-08

On-Brand Devices [Air Tube ]

• B279S29807020002: Mouthpiece
• B279S29807005001: Mouthpiece
• B279F037020002: Mouthpiece
• B279F037005001: Mouthpiece