DYEVERT™ PLUS

GUDID 00815241020003

DyeVert Plus System Contrast Monitoring System

OSPREY MEDICAL INC.

Contrast medium conservation system Contrast medium conservation system Contrast medium conservation system

• Primary Device ID: 00815241020003
• NIH Device Record Key: 38908d94-e65e-452e-b2f4-691548a3d870
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYEVERT™ PLUS
• Version Model Number: CMW
• Company DUNS: 938215568
• Company Name: OSPREY MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: 9529558247
• Email: vfabano@ospreymed.com
• Phone: 9529558247
• Email: vfabano@ospreymed.com
• Phone: 9529558247
• Email: vfabano@ospreymed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815241020003 [Package]; Contains: 00815241020478; Package: CMW-US [1 Units]; In Commercial Distribution
GS1	00815241020478 [Primary]

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-03-13

On-Brand Devices [DYEVERT™ PLUS]

• 00815241020003: DyeVert Plus System Contrast Monitoring System
• 00815241020218: DyeVert Plus Contrast Reduction System
• 00815241020201: DyeVert Plus System Contrast Monitoring System
• 00815241020195: DyeVert Plus Contrast Reduction System
• 00815241020157: DyeVert Plus System Contrast Monitoring System
• 00815241020140: DyeVert Plus System Contrast Monitoring System
• 00815241020133: DyeVert Plus Contrast Reduction System