Catalog Number

DYNDH1522

Brand Name

MEDLINE

Version/Model Number

DYNDH1522

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

OIB

Product Code Name

Blood and urine collection kit (excludes HIV testing)

Public Device Record Key

0071a749-0358-4a38-8cb3-30c92065834e

Public Version Date

May 01, 2020

Public Version Number

1

DI Record Publish Date

April 23, 2020

Package DI Number

20193489194064

Quantity per Package

50

Contains DI Package

10193489194067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE