Smart Monitor

GUDID 00815241020829

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.

OSPREY MEDICAL INC.

Contrast medium conservation system

• Primary Device ID: 00815241020829
• NIH Device Record Key: d54c8101-a6f0-4de9-ada9-d547d8cd75b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Monitor
• Version Model Number: SMART
• Company DUNS: 938215568
• Company Name: OSPREY MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 952-955-8249
• Email: dshertok@ospreymed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815241020829 [Primary]
GS1	00815241020836 [Package]; Package: SMART-US [1 Units]; In Commercial Distribution

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-06
• Device Publish Date: 2019-10-29

Devices Manufactured by OSPREY MEDICAL INC.

• 00815241020416 - DYETECT™ Contrast Monitoring Disposable Kit: 2020-12-09 DyeTect Contrast Monitoring Disposable Kit
• 00815241020430 - DYETECT™ Contrast Monitoring Disposable Kit: 2020-12-09 DyeTect Contrast Monitoring Disposable Kit
• 00815241020485 - SMART SYRINGE: 2020-12-09 Smart Syringe to be used with DyeVert Plus or the CMSW Disposable Kit
• 00815241020492 - SMART SYRINGE: 2020-12-09 Smart Syringe to be used with DyeVert Plus or the CMSW Disposable Kit
• 00815241021031 - DYEVERT™ PLUS EZ: 2020-12-09 DyeVert Plus EZ Contrast Reduction System.
• 00815241021048 - DYEVERT™ PLUS EZ: 2020-12-09 DyeVert Plus EZ Contrast Reduction System.
• 00815241021055 - DYEVERT™ PLUS EZ: 2020-12-09 DyeVert Plus EZ Contrast Reduction System
• 00815241021062 - DYEVERT™ PLUS EZ: 2020-12-09 DyeVert Plus EZ Contrast Reduction System.