Catalog Number

-

Brand Name

Enteral Feeding

Version/Model Number

TL-002Y

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K895367,K895367

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

6b8105f8-7e41-4b0b-a78d-bcbc83838323

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

20020451101099

Quantity per Package

50

Contains DI Package

00020451101095

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-