Infinity 500 mL Feeding Bag Set with Enfit Connector - Infinity 500 mL Feeding Bag Set with Enfit - ZEVEX INTERNATIONAL, INC.

Duns Number:612746933

Device Description: Infinity 500 mL Feeding Bag Set with Enfit Connector

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More Product Details

Catalog Number

INF0500-E

Brand Name

Infinity 500 mL Feeding Bag Set with Enfit Connector

Version/Model Number

INF0500-E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 27, 2021

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PIF

Product Code Name

Gastrointestinal Tubes With Enteral Specific Connectors

Device Record Status

Public Device Record Key

a1a35228-bdd6-47bf-aac5-55dfa0d6513f

Public Version Date

August 16, 2021

Public Version Number

2

DI Record Publish Date

June 01, 2020

Additional Identifiers

Package DI Number

38148440001522

Quantity per Package

30

Contains DI Package

18148440001528

Package Discontinue Date

June 27, 2021

Package Status

Not in Commercial Distribution

Package Type

Carton

"ZEVEX INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 106