Irrigation Pump

Basic Information

• Brand Name: Irrigation Pump
• Primary DI: 00607915127572
• Version / Model: C7000
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• Labeler DUNS: 187129135
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-23
• Public Version: 4
• Public Version Date: 2020-11-06
• Public Version Status: Update
• Public Device Record Key: dcdba53b-f536-4feb-9009-b4f4f9543460
• Distribution End Date: 2019-02-07

Device Description

Reusable Irrigation Pump.

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33579	Surgical irrigation/aspiration pump, reusable	An electrically-powered device, which may include noninvasive accessories, intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic and/or orthopaedic surgical procedure, usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00607915127572	GS1

Customer Contacts

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