ABC - Flex Tube System

GUDID 10841470108622

ENGINEERED MEDICAL SYSTEMS INC

Anaesthesia breathing circuit, single-use

• Primary Device ID: 10841470108622
• NIH Device Record Key: aaed62a0-6ae5-40dc-9ca9-ab44075df747
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABC - Flex Tube System
• Version Model Number: F96M317M0X1A4
• Company DUNS: 154502934
• Company Name: ENGINEERED MEDICAL SYSTEMS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470108625 [Primary]
GS1	10841470108622 [Package]; Contains: 00841470108625; 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: 2025-04-21
• Device Publish Date: 2025-04-11

On-Brand Devices [ABC - Flex Tube System]

• 10841470108622: F96M317M0X1A4
• 10841470106345: F060323M0X1E5