RECORDER UNIT

Basic Information

• Brand Name: RECORDER UNIT
• Primary DI: 04953170244506
• Version / Model: OLYMPUS RE-1
• Catalog Number: N2483440
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-21
• Public Version: 2
• Public Version Date: 2024-01-12
• Public Version Status: Update
• Public Device Record Key: 727a19ca-0cbf-4dd9-b739-6d2e309a2e10
• Distribution End Date: 2024-01-11

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Gastroenterology, Urology	876.1300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64666	Video capsule endoscopy system monitor	An electrically-powered, portable component of a video capsule endoscopy system designed to be worn by a patient to continuously display and record photographic image data from an ingested video capsule (not included). It typically incorporates a display and controls and may include connection cables. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170244506	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]