AIR/WATER VALVE

GUDID 04953170156113

MAJ-1248, AIR/WATER VALVE FOR PEF-V

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic procedure air/water valve, reusable

• Primary Device ID: 04953170156113
• NIH Device Record Key: f42ae5e9-86b5-44d1-adad-d9c51aa24167
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIR/WATER VALVE
• Version Model Number: MAJ-1248
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170156113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001766

FDA Product Code

• FDS: Gastroscope and accessories, flexible/rigid

Sterilization

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

[04953170156113]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

On-Brand Devices [AIR/WATER VALVE]

• 04953170209680: MAJ-1444
• 04953170156113: MAJ-1248, AIR/WATER VALVE FOR PEF-V
• 04953170438066: MH-438