DYEVERT™ PLUS EZ

GUDID 00815241020751

DyeVert Plus EZ Contrast Reduction System

OSPREY MEDICAL INC.

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

• Primary Device ID: 00815241020751
• NIH Device Record Key: 449dfe38-f3d2-4a38-b55e-14ffc549350b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYEVERT™ PLUS EZ
• Version Model Number: HV-EZ-PRS
• 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: 9529558249
• Email: dshertok@ospreymed.com
• Phone: 9529558249
• Email: dshertok@ospreymed.com
• Phone: 9529558249
• Email: dshertok@ospreymed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815241020713 [Primary]
GS1	00815241020751 [Package]; Contains: 00815241020713; Package: HV-EZ-PRS-10 [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: 2
• Public Version Date: 2019-10-30
• Device Publish Date: 2018-11-09

On-Brand Devices [DYEVERT™ PLUS EZ]

• 00815241020768: DyeVert Plus EZ Contrast Reduction System
• 00815241020751: DyeVert Plus EZ Contrast Reduction System
• 00815241020805: DyeVert Plus EZ Contrast Reduction System
• 00815241020799: DyeVert Plus EZ Contrast Reduction System
• 00815241020584: DyeVert Plus EZ Contrast Reduction System
• 00815241020577: DyeVert Plus EZ Contrast Reduction System.
• 00815241021062: DyeVert Plus EZ Contrast Reduction System.
• 00815241021055: DyeVert Plus EZ Contrast Reduction System
• 00815241021048: DyeVert Plus EZ Contrast Reduction System.
• 00815241021031: DyeVert Plus EZ Contrast Reduction System.