Compact II breathing system

GUDID 00816472022934

Compact II breathing system - 22mm, 3M extended with luer elbow

Intersurgical Incorporated

Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use

• Primary Device ID: 00816472022934
• NIH Device Record Key: f5a1fd66-0429-4d0a-8cb2-128f445a74c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compact II breathing system
• Version Model Number: 21586000
• 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	00816472022927 [Primary]
GS1	00816472022934 [Package]; Contains: 00816472022927; Package: [10 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-03
• Device Publish Date: 2023-04-25

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