Catalog Number

ENFIT70554

Brand Name

Medline

Version/Model Number

ENFIT70554

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

bd6b4033-4862-45c2-8e52-eb4b08c5cd89

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2016

Package DI Number

20888277410500

Quantity per Package

30

Contains DI Package

10888277410503

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE