UniFlow™ Coaxial Breathing System

GUDID 00816472023078

UniFlow™ Coaxial Breathing System 30mm with Integrated Monitor Line 0.5M Limb, 1.6M

Intersurgical Incorporated

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• Primary Device ID: 00816472023078
• NIH Device Record Key: 5fd74219-623b-475d-a30c-d070ae9ee96d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniFlow™ Coaxial Breathing System
• Version Model Number: 29026000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816472023061 [Primary]
GS1	00816472023078 [Package]; Contains: 00816472023061; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• CAI: Circuit, Breathing (W Connector, Adaptor, Y Piece)

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: 2023-05-12
• Device Publish Date: 2023-05-04

Devices Manufactured by Intersurgical Incorporated

• 05030267166077 - VENTURI VALVE 24% OXYGEN, BLUE: 2024-04-12 VENTURI VALVE 24% OXYGEN, BLUE
• 05030267166145 - VENTURI VALVE 28% OXYGEN, WHITE: 2024-04-12 VENTURI VALVE 28% OXYGEN, WHITE
• 05030267166176 - VENTURI VALVE 35% OXYGEN, YELLOW: 2024-04-12 VENTURI VALVE 35% OXYGEN, YELLOW
• 05030267166206 - VENTURI VALVE 40% OXYGEN, RED: 2024-04-12 VENTURI VALVE 40% OXYGEN, RED
• 05030267166237 - VENTURI VALVE 60% OXYGEN, GREEN: 2024-04-12 VENTURI VALVE 60% OXYGEN, GREEN
• 05030267166268 - VENTURI VALVE 50% OXYGEN, PINK: 2024-04-12 VENTURI VALVE 50% OXYGEN, PINK
• 05030267166299 - VENTURI VALVE 31% OXYGEN, ORANGE: 2024-04-12 VENTURI VALVE 31% OXYGEN, ORANGE
• 05030267011674 - MONITORING LINE 1.8M, MALE - MALE LUER LOCK CONNECTORS: 2024-02-28 MONITORING LINE 1.8M, MALE - MALE LUER LOCK CONNECTORS