REPROCESSING DATA CAPTURE UNIT

Basic Information

• Brand Name: REPROCESSING DATA CAPTURE UNIT
• Primary DI: 04953170336935
• Version / Model: MAJ-2022
• 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: 2021-12-18
• Public Version: 2
• Public Version Date: 2023-04-03
• Public Version Status: Update
• Public Device Record Key: dbe3a787-08e7-4455-a908-59dea7527174
• Distribution End Date: 2023-03-31

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUG	Medical Device Data System	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64639	Endoscope washer/disinfector data recorder	An electrically-powered device designed to be connected to an endoscope washer/disinfector to electronically record the instrument’s operation events (e.g., operation history, washing/disinfection cycle completion, reprocessing results and errors). The device in addition allows the recorded data to be transferred to a computing device (e.g., via a USB stick).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170336935	GS1

Customer Contacts

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