22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE 5183010

GUDID 05030267165285

22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEL ELBOW. 1.6M

Intersurgical Incorporated

Ventilator breathing circuit, single-use

• Primary Device ID: 05030267165285
• NIH Device Record Key: f2e23aed-35f3-4191-b4d6-3f59058917ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE
• Version Model Number: 5183010
• Catalog Number: 5183010
• Company DUNS: 785952607
• Company Name: Intersurgical Incorporated
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05030267165278 [Primary]
GS1	05030267165285 [Package]; Contains: 05030267165278; 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: 2025-04-23
• Device Publish Date: 2025-04-15

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• 05030267165285 - 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE: 2025-04-2322MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEL ELBOW. 1.6M
• 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
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