22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6M

GUDID 05030267033669

22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS. > 1.6M

Intersurgical Incorporated

Ventilator breathing circuit, single-use

• Primary Device ID: 05030267033669
• NIH Device Record Key: 778730cd-8487-4544-87e0-a829c0f60b16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6M
• Version Model Number: 2026000
• 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
• 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	05030267033669 [Package]; Contains: 05030267060658; Package: [10 Units]; In Commercial Distribution
GS1	05030267060658 [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: 2025-03-24
• Device Publish Date: 2025-03-14

Devices Manufactured by Intersurgical Incorporated

• 05030267124084 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15M: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15M
• 05030267124091 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M
• 05030267124107 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F
• 05030267123582 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F
• 05030267124121 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F
• 05030267124077 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F
• 05030267124138 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22: 2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22F
• 05030267165322 - I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT: 2025-10-01 I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT