EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V N5992941

GUDID 04953170452024

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video duodenoscope, reusable

• Primary Device ID: 04953170452024
• NIH Device Record Key: e0e4ccc9-0960-470d-8723-0c643addd416
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
• Version Model Number: TJF-Q190V
• Catalog Number: N5992941
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: false
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170452024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220587

FDA Product Code

• FDT: Duodenoscope And Accessories, Flexible/Rigid

Sterilization

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

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

[04953170452024]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-09
• Device Publish Date: 2022-06-01

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

• 04953170452475 - EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE: 2024-10-14
• 04953170464935 - THUNDERBEAT 5 mm, 45 cm, Pistol Grip: 2024-09-17
• 04953170464973 - THUNDERBEAT 5 mm, 35 cm, Inline Grip: 2024-09-17
• 04953170464980 - THUNDERBEAT 5 mm, 45 cm, Inline Grip: 2024-09-17
• 14953170464994 - SONICBEAT 5 mm, 10 cm, Inline Grip: 2024-09-17
• 14953170465021 - SONICBEAT 5 mm, 35 cm, Pistol Grip: 2024-09-17
• 14953170465045 - SONICBEAT 5 mm, 45 cm, Pistol Grip: 2024-09-17
• 14953170409971 - Single Use Aspiration Needle NA-U401SX: 2024-07-11