Catalog Number

70-0064-114

Brand Name

Gastrostomy Tube with ENFit connector

Version/Model Number

ENFIT70314

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K142075,K142075

Product Code

PIF

Product Code Name

Gastrointestinal Tubes With Enteral Specific Connectors

Public Device Record Key

18254c03-366f-4d2b-bcb4-9f72cfce207a

Public Version Date

May 04, 2021

Public Version Number

6

DI Record Publish Date

August 08, 2016

Package DI Number

20888277411033

Quantity per Package

5

Contains DI Package

10888277411036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Box