Infinity 100 mL Feeding Bag Set with Enfit Connector - Infinity 100 mL Feeding Bag Set with Enfit - ZEVEX INTERNATIONAL, INC.

Duns Number:612746933

Device Description: Infinity 100 mL Feeding Bag Set with Enfit Connector

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More Product Details

Catalog Number

INF0100-E

Brand Name

Infinity 100 mL Feeding Bag Set with Enfit Connector

Version/Model Number

INF0100-E

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

00583afd-df53-4b14-8ee5-29dbf59c9fe9

Public Version Date

October 04, 2021

Public Version Number

1

DI Record Publish Date

September 24, 2021

Additional Identifiers

Package DI Number

30814844001977

Quantity per Package

30

Contains DI Package

10814844001973

Package Discontinue Date

-

Package Status

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