Elution Test Vial Shield

Basic Information

• Brand Name: Elution Test Vial Shield
• Primary DI: 10815112020085
• Version / Model: 001550
• Company Name: BRACCO DIAGNOSTICS INC
• Labeler DUNS: 849234661
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-21
• Public Version: 1
• Public Version Date: 2023-03-29
• Public Version Status: New
• Public Device Record Key: 94e613bd-5add-436a-8e62-a4d2edb26d81

Device Description

Elution Test Vial Shield for use with CardioGen-82 Infusion System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWW	Shield, Vial	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38380	Vial radiation shield	A device, sometimes called a vial holder, designed to partially or completely surround a vial or a container of a solid or liquid radioactive material. It protects persons from unnecessary radiation exposure by partially or totally blocking the radiation emissions from a vial or similar container holding a radiopharmaceutical or other radioactive material used in diagnostic or therapeutic procedures. It is made of lead (Pb) or lead-equivalent materials, the shielding properties may vary depending on the isotopes they are intended to be used with. Some include an opening that allows needle access to the vial contents and some are either totally transparent or include a window.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815112020085	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]