Catalog Number

OR520ANS

Brand Name

Medline

Version/Model Number

OR520ANS

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

BYY

Product Code Name

TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Public Device Record Key

8c8f31a2-85e8-448a-a273-4804c4cbdace

Public Version Date

January 11, 2021

Public Version Number

1

DI Record Publish Date

January 02, 2021

Package DI Number

20888277657028

Quantity per Package

30

Contains DI Package

10888277657021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE