Smart Monitor

Basic Information

• Brand Name: Smart Monitor
• Primary DI: 00815241020829
• Version / Model: SMART
• Company Name: OSPREY MEDICAL INC.
• Labeler DUNS: 938215568
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-29
• Public Version: 1
• Public Version Date: 2019-11-06
• Public Version Status: New
• Public Device Record Key: d54c8101-a6f0-4de9-ada9-d547d8cd75b7

Device Description

The device consists of a Smart Monitor to be used with the DyeVert or DyeTect systems during angiographic or CT procedures requiring controlled infusion of radiopaque contrast media.

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: MR Unsafe
• 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
DXT	Injector And Syringe, Angiographic	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36310	Contrast medium conservation system	An assembly of electromechanical devices that serves a contrast medium injector system by controlling the amount of contrast agent supplied to the syringe/injector portion of the contrast medium injector system. It is designed to optimise the use of injectible contrast agents in order to prevent unnecessary waste of contrast media during and/or between patient procedures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815241020829	GS1
Package	00815241020836	GS1	SMART-US	1	In Commercial Distribution

Customer Contacts

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