DYETECT™ Contrast Monitoring Disposable Kit

GUDID 00815241020461

DyeTect Contrast Monitoring Disposable Kit

OSPREY MEDICAL INC.

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

• Primary Device ID: 00815241020461
• NIH Device Record Key: 6fb87849-9c85-49d2-9327-9fafd08f7bcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYETECT™ Contrast Monitoring Disposable Kit
• Version Model Number: 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: 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	00815241020461 [Primary]

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: 2018-02-23

On-Brand Devices [DYETECT™ Contrast Monitoring Disposable Kit]

• 00815241020461: DyeTect Contrast Monitoring Disposable Kit
• 00815241020447: DyeTect Contrast Monitoring Disposable Kit
• 00815241020423: DyeTect Contrast Monitoring Disposable Kit
• 00815241020430: DyeTect Contrast Monitoring Disposable Kit
• 00815241020416: DyeTect Contrast Monitoring Disposable Kit