Enteral 1200 mL Gravity Feeding Bag - ZEVEX INTERNATIONAL, INC.

Duns Number:612746933

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More Product Details

Catalog Number

-

Brand Name

Enteral 1200 mL Gravity Feeding Bag

Version/Model Number

GR1200

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 03, 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)

-

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

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

ad945fe5-f790-4d1b-a982-78da7280507e

Public Version Date

November 04, 2021

Public Version Number

4

DI Record Publish Date

October 21, 2016

Additional Identifiers

Package DI Number

38148440000839

Quantity per Package

30

Contains DI Package

18148440000835

Package Discontinue Date

November 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