SMART SYRINGE

GUDID 00815241020522

Smart Syringe to be used with DyeVert Plus or the DyeTect Disposable Kit

OSPREY MEDICAL INC.

Contrast medium conservation system

• Primary Device ID: 00815241020522
• NIH Device Record Key: a94032d4-a079-4e02-ba33-727e937c35bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMART SYRINGE
• Version Model Number: R-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	00815241020522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171698

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: 4
• Public Version Date: 2019-10-30
• Device Publish Date: 2017-08-11

On-Brand Devices [SMART SYRINGE]

• 00815241020522: Smart Syringe to be used with DyeVert Plus or the DyeTect Disposable Kit
• 00815241020515: Smart Syringe to be used with DyeVert Plus or the CMSW Disposable Kit
• 00815241020508: Smart Syringe to be used with DyeVert Plus or the DyeTect Disposable Kit
• 00815241020492: Smart Syringe to be used with DyeVert Plus or the CMSW Disposable Kit
• 00815241020485: Smart Syringe to be used with DyeVert Plus or the CMSW Disposable Kit