Rymed

Basic Information

• Brand Name: Rymed
• Primary DI: 00817903010001
• Version / Model: RYM-5001
• Company Name: RYMED TECHNOLOGIES, LLC
• Labeler DUNS: 079219081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 4
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: d93b6a99-fcde-47f3-90c6-0d2ccee062a6

Device Description

In Vision Plus, Needleless IV Connector

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42750	Neutral-pressure intravenous line needleless valve-connector	A small, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point there is minimal fluid flow into or out of the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817903010005	GS1	Case	5	In Commercial Distribution
Package	10817903010008	GS1	Inner pack	200	In Commercial Distribution
Primary	00817903010001	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K991653	000