OLYMPUS

Basic Information

• Brand Name: OLYMPUS
• Primary DI: 15019778003191
• Version / Model: OFP-2 (US)
• Company Name: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED
• Labeler DUNS: 217061423
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: dc0181ed-cb9c-4db4-bd6a-2a655c00b50a

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: 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
FEQ	Pump, Air, Non-Manual, For Endoscope	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	15019778003191	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: ROOM TEMPERATURE
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: -40 – 70 Degrees Celsius