Vented Cap for Waste Bottle

Basic Information

• Brand Name: Vented Cap for Waste Bottle
• Primary DI: 10815112021365
• Version / Model: 001511
• Company Name: BRACCO DIAGNOSTICS INC
• Labeler DUNS: 849234661
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2023-10-16
• Public Version: 2
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: c6f9d3f6-b1ea-4f8d-af26-7365a634f9f0

Device Description

Vented Cap for Waste Bottle 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
46237	General laboratory container, single-use	A container (e.g., test tube, bottle, cup, assay tray with large wells) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30815112021369	GS1		12	In Commercial Distribution
Primary	10815112021365	GS1
Unit of Use	00815112021368	GS1

Customer Contacts

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