CO2 Source Tubing Filter Olympus

GUDID 10858276007974

CO2 Source Tubing Filter Olympus, Sterile, Single Day Use.

Micro-tech Usa

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 10858276007974
• NIH Device Record Key: c09554a0-0aca-4fce-9570-d6f0dcb21bd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CO2 Source Tubing Filter Olympus
• Version Model Number: BW02-CO2TUBOLY
• Company DUNS: 079873914
• Company Name: Micro-tech Usa
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858276007977 [Primary]
GS1	10858276007974 [Package]; Contains: 00858276007977; Package: Box [15 Units]; In Commercial Distribution
GS1	20858276007971 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220785

FDA Product Code

• OCX: Endoscopic Irrigation/Suction System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-20
• Device Publish Date: 2025-05-12

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