3-Piece Valve Kit

GUDID 10850025860878

A/W Suc Valve Kit L Fuj 3 Piece 700

Micro-tech Usa

Endoscope channel support kit

• Primary Device ID: 10850025860878
• NIH Device Record Key: ce93a963-7b23-4c40-aa6e-2d6db1ba2a11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3-Piece Valve Kit
• Version Model Number: BW01-FUJ3-F7
• 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	00850025860871 [Primary]
GS1	10850025860878 [Package]; Contains: 00850025860871; Package: Box [50 Units]; In Commercial Distribution
GS1	20850025860875 [Package]; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220210

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: 2025-03-12
• Device Publish Date: 2025-03-04

On-Brand Devices [3-Piece Valve Kit]

• 10850025860731: A/W Suction Valve Kit Lub Oly 3 Piece
• 00850025860611: Air/Water Suction Valve Kit Pen 3 Piece
• 00850025860598: Air/Water Suction Valve Kit Oly 3 Piece
• 10850025860878: A/W Suc Valve Kit L Fuj 3 Piece 700
• 10850025860755: A/W Suction Valve Kit Lub Pen 3 Piece