Channel Plug

GUDID 04953170062063

OLYMPUS MEDICAL SYSTEMS CORP.

Oesophageal ultrasound imaging transducer, reusable

• Primary Device ID: 04953170062063
• NIH Device Record Key: 839e73dc-69e2-4d99-93a9-b634329cd65d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Channel Plug
• Version Model Number: MAJ-621
• 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: false
• 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
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170062063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021886
• Premarket Notification: K093395

FDA Product Code

• FDS: Gastroscope and accessories, flexible/rigid
• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

[04953170062063]

Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2018-10-08
• Device Publish Date: 2017-10-12

On-Brand Devices [Channel Plug]

• 04953170154317: MAJ-1231, CHANNEL PLUG FOR PEF -V
• 04953170062063: MAJ-621
• 04953170437724: MH-944