Catalog Number

YM54-5201

Brand Name

MED-RX

Version/Model Number

YM54-5201

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

K131183,K131183

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

2ada44cd-f78b-4f83-ac24-ff107887821c

Public Version Date

October 29, 2021

Public Version Number

5

DI Record Publish Date

October 30, 2018

Package DI Number

50628725004971

Quantity per Package

150

Contains DI Package

00628725004976

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-