Filta-Therm™ HMEF with luer port, retainable cap and Flextube™

GUDID 00816472020435

Filta-Therm™ HMEF with luer port, retainable cap and Flextube™

Intersurgical Incorporated

Anaesthesia breathing circuit, single-use

• Primary Device ID: 00816472020435
• NIH Device Record Key: 7ba0d8dd-8e25-40cc-8b2e-6180ed4ad0df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Filta-Therm™ HMEF with luer port, retainable cap and Flextube™
• Version Model Number: 19416500
• Company DUNS: 785952607
• Company Name: Intersurgical Incorporated
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 315-451-2900
• Email: support@intersurgicalinc.com
• Phone: 315-451-2900
• Email: support@intersurgicalinc.com
• Phone: 315-451-2900
• Email: support@intersurgicalinc.com
• Phone: 315-451-2900
• Email: support@intersurgicalinc.com
• Phone: 315-451-2900
• Email: support@intersurgicalinc.com
• Phone: 315-451-2900
• Email: support@intersurgicalinc.com
• Phone: 315-451-2900
• Email: support@intersurgicalinc.com
• Phone: 315-451-2900
• Email: support@intersurgicalinc.com
• Phone: 315-451-2900
• Email: support@intersurgicalinc.com
• Phone: 315-451-2900
• Email: support@intersurgicalinc.com
• Phone: 315-451-2900
• Email: support@intersurgicalinc.com
• Phone: 315-451-2900
• Email: support@intersurgicalinc.com
• Phone: 315-451-2900
• Email: support@intersurgicalinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816472020428 [Primary]
GS1	00816472020435 [Package]; Contains: 00816472020428; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• OFP: Anesthesia Breathing Circuit Kit (Adult & Pediatric)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-02-11
• Device Publish Date: 2023-01-12

Devices Manufactured by Intersurgical Incorporated

• 00816472020435 - Filta-Therm™ HMEF with luer port, retainable cap and Flextube™: 2025-02-11Filta-Therm™ HMEF with luer port, retainable cap and Flextube™
• 00816472020435 - Filta-Therm™ HMEF with luer port, retainable cap and Flextube™: 2025-02-11 Filta-Therm™ HMEF with luer port, retainable cap and Flextube™
• 00816472020558 - Breathing Circuit: 2025-02-11 Breathing Circuit, 22mm, nonconductive, single use, MRI Safe
• 00816472020695 - Convenience Pack with 12" Flex Tube: 2025-02-11 Convenience Pack with 12" Flex Tube
• 00816472021852 - Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line: 2025-02-11 Sentri Intersurgical EcoLite, adult, mask with CO2 monitoring line with universal connector tube, 1.8m
• 00816472022217 - Smoothbore breathing system without exhalation port, 22mm, 1.6m: 2025-02-11 Smoothbore breathing system without exhalation port, 22mm, 1.6m
• 00816472022538 - Multipac® Anesthesia Breathing System: 2025-02-11 Multipac® Anesthesia Breathing System
• 00816472023610 - Smoothbore circuit, 22mm: 2025-02-11 Smoothbore circuit, 22mm
• 00816472023696 - Multipac Anesthesia Breathing Circuit: 2025-02-11 Multipac Anesthesia Breathing Circuit