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

• 05030267033669 - 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6M: 2025-03-24 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS. > 1.6M
• 05030267097913 - 22MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6M: 2025-03-24 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. > 1.6M
• 05030267033683 - 22MM SMOOTHBORE SINGLE H/W BREATHING SYSTEM WITH WATER TRAP AND LIMB.>1.6M: 2025-03-24 22MM SMOOTHBORE SINGLE HEATED WIRE BREATHING SYSTEM WITH WATER TRAP AND LIMB. > 1.6M
• 05030267096374 - 22MM SMOOTHBORE SINGLE H/W B/S WITH WATER TRAP,AUTO-FILL CHAMBER,EXTRA LIMB>1.6M: 2025-03-24 22MM SMOOTHBORE SINGLE HEATED WIRE BREATHING SYSTEM WITH WATER TRAP, AUTO-FILL CHAMBER AND EXTRA LIMB. > 1.6M
• 05030267033676 - 22MM SMOOTHBORE DUAL H/W BREATHING SYSTEM WITH EXTRA LIMB. > 1.6M: 2025-03-24 22MM SMOOTHBORE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMB. > 1.6M
• 05030267167678 - UNIVERSAL STYLET BOUGIE (USB) WITHOUT SACHET OF LUBRICANT: 2025-03-24 UNIVERSAL STYLET BOUGIE (USB) WITHOUT SACHET OF LUBRICANT
• 05030267161928 - 22MM FLEXTUBE SINGLE H/W LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB.>1.6M: 2025-03-24 22MM FLEXTUBE SINGLE HEATED WIRE LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB. > 1.6M
• 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™