Endoscopy Kit - Compliance+ FUJ5 Kit

GUDID 10858276007981

Endoscopy Kit, Compliance+, Sterile Lube 1.4oz, Gauze, Basin, FUJ5 Valve Set, Pad, Single Use

Micro-tech Usa

Endoscopy preparation kit

• Primary Device ID: 10858276007981
• NIH Device Record Key: f7ccef47-00e1-443c-9519-065edcffd5d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoscopy Kit - Compliance+ FUJ5 Kit
• Version Model Number: KT1A0010A
• 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: true
• 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	00858276007984 [Primary]
GS1	10858276007981 [Package]; Contains: 00858276007984; Package: Box [30 Units]; In Commercial Distribution
GS1	20858276007988 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• ODC: Endoscope Channel Accessory

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

Devices Manufactured by Micro-tech Usa

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• 10850025860908 - CO2 Source Tubing Filter Adapter Olympus: 2025-05-20 CO2 Source Tubing Filter Adapter Olympus, Sterile, Single Day Use.
• 10858276007974 - CO2 Source Tubing Filter Olympus: 2025-05-20 CO2 Source Tubing Filter Olympus, Sterile, Single Day Use.
• 10858276007981 - Endoscopy Kit - Compliance+ FUJ5 Kit: 2025-05-20Endoscopy Kit, Compliance+, Sterile Lube 1.4oz, Gauze, Basin, FUJ5 Valve Set, Pad, Single Use
• 10858276007981 - Endoscopy Kit - Compliance+ FUJ5 Kit: 2025-05-20 Endoscopy Kit, Compliance+, Sterile Lube 1.4oz, Gauze, Basin, FUJ5 Valve Set, Pad, Single Use
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• 10850025860816 - Scope Tip Protector: 2025-03-19 Distal Tip Protector Large
• 00850025860437 - Irrigation Tubing Set: 2025-03-17 Irrigation Tubing Set