Catalog Number

URO170916

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

URO170916

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

e0ba9fdc-044f-4b21-b1e0-4258c73d9596

Public Version Date

March 26, 2021

Public Version Number

1

DI Record Publish Date

March 18, 2021

Package DI Number

40889942515982

Quantity per Package

10

Contains DI Package

10889942515981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE