22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE 5191850

GUDID 05030267045952

22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE AND LIMB.1.6M

Intersurgical Incorporated

Ventilator breathing circuit, single-use

• Primary Device ID: 05030267045952
• NIH Device Record Key: 3072ec85-0e6f-4e02-bf05-ebe193056010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE
• Version Model Number: 5191850
• Catalog Number: 5191850
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05030267045952 [Package]; Contains: 05030267069897; Package: [25 Units]; In Commercial Distribution
GS1	05030267069897 [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: 2025-04-24
• Device Publish Date: 2025-04-16

Devices Manufactured by Intersurgical Incorporated

• 05030267045952 - 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE: 2025-04-2422MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE AND LIMB.1.6M
• 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
• 00816472022552 - Nose Clip with Padding: 2025-04-22 Nose Clip with Padding
• 05030267161546 - 22mm Compact breathing system: 2025-04-22 22mm Compact breathing system with 3L bag, elbow, monitoring line, anesthetic face mask and HMEF >3m
• 05030267161751 - 22mm Compact breathing system: 2025-04-22 22mm Compact breathing system with 3L bag, monitoring line, HMEF, and Clearlite facemask >3 m