Infinity - Enteralite Infinity Super Mini Backpack, Black - ZEVEX INTERNATIONAL, INC.

Duns Number:612746933

Device Description: Enteralite Infinity Super Mini Backpack, Black

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More Product Details

Catalog Number

50749-001

Brand Name

Infinity

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 03, 2021

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Prescription Use (Rx)

-

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

LZH

Product Code Name

Pump, Infusion, Enteral

Device Record Status

Public Device Record Key

8d5a974f-cb16-45bc-a3d2-4b6da5b7e33f

Public Version Date

May 07, 2021

Public Version Number

5

DI Record Publish Date

August 03, 2018

Additional Identifiers

Package DI Number

38148440000136

Quantity per Package

3

Contains DI Package

18148440000132

Package Discontinue Date

March 03, 2021

Package Status

Not in Commercial Distribution

Package Type

-

"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