Catalog Number

OR139

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

OR139

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

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Public Device Record Key

7bf603ca-3ca6-4aed-bbc6-3130773de3c5

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

December 31, 2020

Package DI Number

20888277407968

Quantity per Package

20

Contains DI Package

10888277407961

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE