SMART SYRINGE

GUDID 00815241020522

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

OSPREY MEDICAL INC.

Contrast medium conservation system Contrast medium conservation system 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