30mm UniFlow coaxial breathing system with 0.5m limb, 1.6m

GUDID 00816472022996

30mm UniFlow coaxial breathing system with 0.5m limb, 1.6m

Intersurgical Incorporated

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• Primary Device ID: 00816472022996
• NIH Device Record Key: e4d0b4be-a396-4726-b69f-a25cf3c6ac53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 30mm UniFlow coaxial breathing system with 0.5m limb, 1.6m
• Version Model Number: 29006000
• 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	00816472022989 [Primary]
GS1	00816472022996 [Package]; Contains: 00816472022989; 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

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• 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