Jacket Air/Water & Suction Valve Kit

GUDID 00858276007830

Air/Water & Suction, Valve Kit

Micro-tech Usa

Endoscope channel support kit

• Primary Device ID: 00858276007830
• NIH Device Record Key: 7dfa40dd-4ab5-4baa-bb3d-7136c01d9291
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jacket Air/Water & Suction Valve Kit
• Version Model Number: MD-A-AW01
• 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	00858276007823 [Primary]
GS1	00858276007830 [Package]; Contains: 00858276007823; Package: Box [50 Units]; In Commercial Distribution
GS1	00858276007847 [Package]; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192258

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 [Jacket Air/Water & Suction Valve Kit]

• 00858276007830: Air/Water & Suction, Valve Kit
• 00858276007809: Air/Water, Suction, Biopsy Valve Kit