ALL-CHANNEL IRRIGATOR

GUDID 04953170286445

CW-3 ALL CHANNEL IRRIGATOR W 30CC SYRING

OLYMPUS MEDICAL SYSTEMS CORP.

Luer/non-ISO80369-standardized linear connector, reusable

• Primary Device ID: 04953170286445
• NIH Device Record Key: 81f0a75e-04f6-4c4b-9905-377875e560b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALL-CHANNEL IRRIGATOR
• Version Model Number: CW-3
• 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
• 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	04953170286445 [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

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

[04953170286445]

Ethylene Oxide;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-21

On-Brand Devices [ALL-CHANNEL IRRIGATOR]

• 04953170355691: CW-5 MH-908 channel irrigator w/30cc syr
• 04953170286445: CW-3 ALL CHANNEL IRRIGATOR W 30CC SYRING
• 04953170055591: CW-5
• 04953170437755: CW-3