Infinity 500 mL Feeding Bag Set with Enfit Connector

Basic Information

• Brand Name: Infinity 500 mL Feeding Bag Set with Enfit Connector
• Primary DI: 18148440001528
• Version / Model: INF0500-E
• Catalog Number: INF0500-E
• Company Name: ZEVEX INTERNATIONAL, INC.
• Labeler DUNS: 612746933
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-01
• Public Version: 2
• Public Version Date: 2021-08-16
• Public Version Status: Update
• Public Device Record Key: a1a35228-bdd6-47bf-aac5-55dfa0d6513f
• Distribution End Date: 2021-06-27

Device Description

Infinity 500 mL Feeding Bag Set with Enfit Connector

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: No
• 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
11675	Enteral feeding bag/bottle	An empty pouch or bottle made of plastic or glass intended to contain a fluid of nutrients for administration to a patient through an enteral tube that provides direct access to the stomach, duodenum, or jejunum; it is not intended for intravenous (IV) administration. It may be composed of one or more chambers and might be provided with a short length of tubing; however, it does not include other associated items (e.g., clamp, spike) [i.e., not an enteral feeding set] and is not intended to be directly connected to the invasive feeding tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	38148440001522	GS1	Carton	30	Not in Commercial Distribution	2021-06-27
Primary	18148440001528	GS1

Customer Contacts

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