Endoflow II US - Single Chamber

Basic Information

• Brand Name: Endoflow II US - Single Chamber
• Primary DI: 03700512955139
• Version / Model: MEN01US
• Catalog Number: MEN01US
• Company Name: Promepla
• Labeler DUNS: 401020409
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-11
• Public Version: 4
• Public Version Date: 2019-11-11
• Public Version Status: Update
• Public Device Record Key: efa8a2c9-5f65-4038-b8be-7ae271102b41

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
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36023	Endoscopic irrigation/aspiration pump	A mains electricity (AC-powered) device intended to generate positive and/or negative pressures, to irrigate and/or aspirate a body cavity or lumen with sterile fluid (e.g., saline water) through an endoscope typically to facilitate observation of a site with an endoscope (e.g., during arthroscopy), and/or to keep clear the working channel of an endoscope or lumen of a catheter.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700512955139	GS1

Customer Contacts

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