Catalog Number

OR712

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

OR712

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

923eceb7-7bdb-4025-bc05-3e063f1f7c0c

Public Version Date

April 25, 2022

Public Version Number

1

DI Record Publish Date

April 15, 2022

Package DI Number

40888277322715

Quantity per Package

20

Contains DI Package

10888277322714

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE