Catalog Number

UROT1036

Brand Name

Medline

Version/Model Number

UROT1036

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

6bee2505-0b06-4379-abd7-4afcc0d6f88a

Public Version Date

March 25, 2021

Public Version Number

1

DI Record Publish Date

March 17, 2021

Package DI Number

40889942652847

Quantity per Package

10

Contains DI Package

10889942652846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE