Catalog Number

OR610NS

Brand Name

Medline

Version/Model Number

OR610NS

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

fbb3bc7a-d254-4ea5-bb54-13224ce07795

Public Version Date

January 11, 2021

Public Version Number

1

DI Record Publish Date

January 02, 2021

Package DI Number

20888277656823

Quantity per Package

50

Contains DI Package

10888277656826

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE