Catalog Number

ENT921

Brand Name

Medline

Version/Model Number

ENT921

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

430ce8b9-b74a-4714-8492-d3496cc4d70a

Public Version Date

January 20, 2021

Public Version Number

1

DI Record Publish Date

January 12, 2021

Package DI Number

20888277699820

Quantity per Package

10

Contains DI Package

10888277699823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX