DYEVERT™ PLUS

GUDID 00815241020140

DyeVert Plus System Contrast Monitoring System

OSPREY MEDICAL INC.

Contrast medium conservation system

• Primary Device ID: 00815241020140
• NIH Device Record Key: d4ab0b6b-5b3b-4dcc-a887-2c3c1e0fc701
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYEVERT™ PLUS
• Version Model Number: HVOFF-RRS
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00815241020140 [Primary]
GS1	00815241020546 [Package]; Package: 10-Pack [10 Units]; In Commercial Distribution

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-30
• 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