Catalog Number

RTU12M

Brand Name

BD Intermittent

Version/Model Number

RTU12M

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

K192468,K192468,K192468

Product Code

EZD

Product Code Name

Catheter, Straight

Public Device Record Key

ef3b7164-8200-476e-bad6-c1bfaa524f55

Public Version Date

February 01, 2021

Public Version Number

1

DI Record Publish Date

January 23, 2021

Package DI Number

16948796203957

Quantity per Package

30

Contains DI Package

06948796203950

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA