DyeVert

GUDID 00081524102004

DYEVERT™ CONTRAST MODULATION SYSTEM

OSPREY MEDICAL INC.

Contrast medium conservation system

• Primary Device ID: 00081524102004
• NIH Device Record Key: b946c1b5-5462-4e63-b713-8583aff168fa
• Commercial Distribution Discontinuation: 2018-02-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DyeVert
• Version Model Number: AA-LV
• Company DUNS: 938215568
• Company Name: OSPREY MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00081524102004 [Primary]

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

[00081524102004]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-07-01

On-Brand Devices [DyeVert]

• 00081524102004: DYEVERT™ CONTRAST MODULATION SYSTEM
• 00815241020058: DYEVERT™ CONTRAST MODULATION SYSTEM
• 00815241020041: DYEVERT™ CONTRAST MODULATION SYSTEM