Vesco Medical 6Fr 45in Dual Port ENFit NE Tube

Basic Information

• Brand Name: Vesco Medical 6Fr 45in Dual Port ENFit NE Tube
• Primary DI: 00850002550351
• Version / Model: VED-21406
• Company Name: Vesco Medical, LLC
• Labeler DUNS: 119007223
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-16
• Public Version: 1
• Public Version Date: 2023-06-26
• Public Version Status: New
• Public Device Record Key: 1e493fe1-5b7a-46b7-827c-18cd94da68d5

Device Description

6Fr 45in Dual Port ENFit NE Tube

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16798	Nasoenteral tube	A sterile, thin, flexible, hollow cylinder designed to access the small intestines (duodenum or jejunum) through the nose and nasopharynx for examination (e.g., of intestinal contents), treatment (e.g., decompression, short-term feeding), or other purposes. It is a single- or dual-lumen, rubber or plastic tube (nasoduodenal or nasojejunal tube) that is smaller and longer than a nasogastric tube and may have a small weight or magnet at the distal tip to facilitate placement. It is frequently used for very ill or comatose patients. Some types are used to remove air and liquids from the stomach by connection to intermittent suction units and/or for enteral feeding. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850002550358	GS1	Case	10	In Commercial Distribution
Primary	00850002550351	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K170162	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	6	French
Length	45	Inch