MANIFOLD

Basic Information

• Brand Name: MANIFOLD
• Primary DI: 00850004162026
• Version / Model: VGAM0301
• Catalog Number: VGAM0301
• Company Name: VALFLUX GROUP, LLC
• Labeler DUNS: 050193715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-19
• Public Version: 2
• Public Version Date: 2021-02-19
• Public Version Status: Update
• Public Device Record Key: fe62c161-ddfb-4aa6-82db-c6bf87ad8b22

Device Description

VGAM0301 MANIFOLD

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTL	Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass	Cardiovascular	870.4290	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47258	Contrast medium injection system administration set	A collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer; it is typically made of plastic materials. This is a disposable device which may serve multiple patients before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850004162026	GS1

Customer Contacts

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