Catalog Number

URO180218

Brand Name

Medline

Version/Model Number

URO180218

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)

Yes

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

-

Product Code

OHR

Product Code Name

Catheter care tray

Public Device Record Key

5032f0e2-20d6-475a-b909-e7dd34e4e560

Public Version Date

November 17, 2021

Public Version Number

1

DI Record Publish Date

November 09, 2021

Package DI Number

20888277716138

Quantity per Package

10

Contains DI Package

10888277716131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE