Catalog Number

OR512

Brand Name

Medline

Version/Model Number

OR512

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

e6ebfec4-70c6-4089-ba92-2d293c2d0a50

Public Version Date

January 01, 2021

Public Version Number

1

DI Record Publish Date

December 24, 2020

Package DI Number

40888277319142

Quantity per Package

20

Contains DI Package

10888277319141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE