Catalog Number

UROT1049

Brand Name

Medline

Version/Model Number

UROT1049

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

-

Product Code

OHR

Product Code Name

Catheter care tray

Public Device Record Key

bd0eaeb9-d583-4f71-880b-5f64c9f44846

Public Version Date

March 23, 2021

Public Version Number

1

DI Record Publish Date

March 15, 2021

Package DI Number

40888277775955

Quantity per Package

10

Contains DI Package

10888277775954

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE