Bonhawa Respiratory Humidifier

GUDID 00850057298000

Telesair, Inc.

Professional high-flow respiratory unit, humidifying, manual

• Primary Device ID: 00850057298000
• NIH Device Record Key: 79af24bc-058c-456b-aa4a-da74e296a25a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bonhawa Respiratory Humidifier
• Version Model Number: RHFG303
• Company DUNS: 117854209
• Company Name: Telesair, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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
GS1	00850057298000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223863

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

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
• 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: 2025-03-20 Contains: (1) Breathing Circuit (1) Water Chamber (1) Water Chamber Adaptor