Catalog Number

-

Brand Name

TubeClear

Version/Model Number

G-1011

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

b992a71c-e5d3-402e-8d18-01bd2df7fd92

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 02, 2017

Package DI Number

20850458007113

Quantity per Package

10

Contains DI Package

00850458007119

Package Discontinue Date

-

Package Status

-

Package Type

Carton