Heated Breathing Set

GUDID 00860009312296

Contains: (1) Breathing Circuit (1) Water Chamber (1) Water Chamber Adaptor

Telesair, Inc.

Ventilator breathing circuit, single-use

• Primary Device ID: 00860009312296
• NIH Device Record Key: c6154d7e-08b1-4eaf-963f-07a4619cbbab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heated Breathing Set
• Version Model Number: HBCK01
• Company DUNS: 117854209
• Company Name: Telesair, Inc.
• Device Count: 1
• 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: true
• Expiration Date: true
• 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
GS1	00860009312296 [Primary]
GS1	10860009312293 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• CAI: Circuit, Breathing (W Connector, Adaptor, Y Piece)

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: 2025-03-20
• Device Publish Date: 2025-03-12

Devices Manufactured by Telesair, Inc.

• 00860009312234 - Bonhawa Air Filter: 2025-03-24
• 00850057298000 - Bonhawa Respiratory Humidifier: 2025-03-20
• 10860009312262 - Adult Nasal Cannula, Small: 2025-03-20
• 10860009312279 - Adult Nasal Cannula, Medium: 2025-03-20
• 10860009312286 - Adult Nasal Cannula, Large: 2025-03-20
• 00860009312296 - Heated Breathing Set: 2025-03-20Contains: (1) Breathing Circuit (1) Water Chamber (1) Water Chamber Adaptor
• 00860009312296 - Heated Breathing Set: 2025-03-20 Contains: (1) Breathing Circuit (1) Water Chamber (1) Water Chamber Adaptor