22MM SMOOTHBORE SINGLE H/W B/S WITH WATER TRAP,AUTO-FILL CHAMBER,EXTRA LIMB>1.6M

GUDID 05030267096374

22MM SMOOTHBORE SINGLE HEATED WIRE BREATHING SYSTEM WITH WATER TRAP, AUTO-FILL CHAMBER AND EXTRA LIMB. > 1.6M

Intersurgical Incorporated

Ventilator breathing circuit, single-use

• Primary Device ID: 05030267096374
• NIH Device Record Key: d689401a-8742-4a63-82ac-6a6ab0b00d6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 22MM SMOOTHBORE SINGLE H/W B/S WITH WATER TRAP,AUTO-FILL CHAMBER,EXTRA LIMB>1.6M
• Version Model Number: 5025310
• 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: 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: 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	05030267069132 [Primary]
GS1	05030267096374 [Package]; Contains: 05030267069132; Package: [7 Units]; In Commercial Distribution

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

Devices Manufactured by Intersurgical Incorporated

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• 05030267165360 - HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULT: 2025-10-01 HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULT
• 05030267045952 - 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE: 2025-04-24 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE AND LIMB.1.6M
• 05030267045884 - 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M: 2025-04-24 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M
• 05030267001804 - TRACHEOSTOMY MASK, PAEDIATRIC: 2025-04-23 TRACHEOSTOMY MASK, PAEDIATRIC
• 05030267098088 - PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M: 2025-04-23 PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M
• 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