DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756730570
• Version / Model: 77-3200
• Catalog Number: 77-3200
• Company Name: Canadian Hospital Specialties Limited
• Labeler DUNS: 240992693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-17
• Public Version: 3
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: b736179e-447f-4b85-a70b-77a7dd03f4bf

Device Description

SWABBABLE VALVE TRANSFER SET WITH UNIVERSAL SPIKE

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00749756730570	GS1
Package	50749756730575	GS1	CORRUGATE	100	In Commercial Distribution