DUO-VENT

Basic Information

• Brand Name: DUO-VENT
• Primary DI: 00085412002750
• Version / Model: 2C7552
• Catalog Number: 2C7552
• Company Name: BAXTER INTERNATIONAL INC.
• Labeler DUNS: 005146311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0f7ac167-4f76-4b4f-a523-0d338008cf8b

Device Description

Nitroglycerin Set with DUO-VENT Spike, PVC Tubing Segment, Injection Site, Male Luer Lock Adapter

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16631	Non-absorbing intravenous administration set	A collection of sterile devices designed for the intravenous (IV) administration of solutions and manufactured with low-absorption plastics to avoid partial absorption of the components of the infused solutions. It typically consists of plastic tubes made of or lined with non absorbing plastics [e.g., polyethylene (PE), Teflon], to avoid solution contact with polyvinyl chloride (PVC) components; it also includes a check valve, a roller clamp, a Y-site connector, and Luer adaptors. The set is mainly used in high-flow infusion pumps for administration of solutions containing products (e.g., nitroglycerin) that are absorbed by PVC materials. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50085412002755	GS1	CASE	48	In Commercial Distribution
Primary	00085412002750	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150860	000