CUFF:INFLATION FOR ROSI

Basic Information

• Brand Name: CUFF:INFLATION FOR ROSI
• Primary DI: 00817122020430
• Version / Model: 200812
• Catalog Number: 200812
• Company Name: VASCULAR TECHNOLOGY, INCORPORATED
• Labeler DUNS: 161989343
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 4
• Public Version Date: 2024-02-08
• Public Version Status: Update
• Public Device Record Key: 41fd5599-68ac-4cae-9998-120c52ef7c4f

Device Description

Part Number 200812, CUFF:INFLATION FOR ROSI

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
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	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	00817122020430	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141323	000