Scope Buddy

Basic Information

• Brand Name: Scope Buddy
• Primary DI: 00677964063640
• Version / Model: EFA-US-G
• Catalog Number: EFAUSG
• Company Name: MEDIVATORS INC.
• Labeler DUNS: 068199363
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-16
• Public Version: 8
• Public Version Date: 2023-08-09
• Public Version Status: Update
• Public Device Record Key: 1cd5d301-9d06-4c94-a221-a8ee0720dc98
• Distribution End Date: 2023-08-08

Device Description

Scope Buddy Endoscope Flushing Aid

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEB	Accessories, Cleaning, For Endoscope	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41663	Laboratory liquid dispenser, electronic	An electronic laboratory device designed to dispense fluid from a stock reservoir (e.g., a bottle or other container). The intended volume is normally user-selected prior to the delivery of the liquid. The device typically has a peristaltic pump for delivery of the preselected volume that typically ranges from 1 ml to 9.99 L. This device can be user operated, automatic, or programmable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00677964063640	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162128	000
K213833	000