ENDOCAPSULE RECORDER

GUDID 04953170328244

OLYMPUS MEDICAL SYSTEMS CORP.

Video capsule endoscopy system workstation

• Primary Device ID: 04953170328244
• NIH Device Record Key: ff32b639-9cd1-4d3d-8194-fde846853efd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOCAPSULE RECORDER
• Version Model Number: RE-10
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170328244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123421
• Premarket Notification: K183053

FDA Product Code

• NEZ: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

• 04953170467219 - HIGH FLOW INSUFFLATION UNIT: 2025-03-07
• 04953170467226 - INSUFFLATION TUBE: 2025-03-06
• 04953170467233 - SUCTION TUBE: 2025-03-06
• 84953170463910 - BALLOON3: 2025-03-05
• 84953170463927 - BALLOON3: 2025-03-05
• 84953170463934 - BALLOON: 2025-03-05
• 04953170465949 - WATER CONTAINER: 2024-12-03
• 04953170465956 - WATER CONTAINER: 2024-12-03