Catalog Number

-

Brand Name

TubeClear

Version/Model Number

NE-1043

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"

-

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

K131052,K131052,K131052

Product Code

FPD

Product Code Name

Tube, Feeding

Public Device Record Key

dc132070-163e-40aa-ad4a-98f5f4977bdd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 27, 2016

Package DI Number

20850458007434

Quantity per Package

10

Contains DI Package

00850458007430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton