22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6M

GUDID 05030267033669

22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS. > 1.6M

Intersurgical Incorporated

Ventilator breathing circuit, single-use

• Primary Device ID: 05030267033669
• NIH Device Record Key: 778730cd-8487-4544-87e0-a829c0f60b16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6M
• Version Model Number: 2026000
• Company DUNS: 785952607
• Company Name: Intersurgical Incorporated
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com
• Phone: +3154512900
• Email: support@intersurgicalinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05030267033669 [Package]; Contains: 05030267060658; Package: [10 Units]; In Commercial Distribution
GS1	05030267060658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092129

FDA Product Code

• BZE: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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: 2025-03-24
• Device Publish Date: 2025-03-14

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• 05030267165285 - 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE: 2025-04-23 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEL ELBOW. 1.6M