22mm Smoothbore breathing system

GUDID 00816472023115

22mm Smoothbore breathing system with monitoring line and exhalation valve, 1.6m

Intersurgical Incorporated

Ventilator breathing circuit, reusable

• Primary Device ID: 00816472023115
• NIH Device Record Key: ae5132cc-c600-4a59-aa53-edc1d88495f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 22mm Smoothbore breathing system
• Version Model Number: 51836000
• Company DUNS: 785952607
• Company Name: Intersurgical Incorporated
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 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
• 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	00816472023108 [Primary]
GS1	00816472023115 [Package]; Contains: 00816472023108; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132143

FDA Product Code

• CBP: Valve, Non-Rebreathing

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: 2023-06-27
• Device Publish Date: 2023-06-19

Devices Manufactured by Intersurgical Incorporated

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• 05030267040865 - 22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6M: 2024-09-24 22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6M
• 05030267166442 - CIRRUS2 NEBULISER 18M WITH TUBE, 1.8M: 2024-09-09 CIRRUS2 NEBULISER 18M WITH TUBE, 1.8M