Compact II breathing system

GUDID 00816472022934

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

Intersurgical Incorporated

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

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