Catalog Number

DYNDH1525

Brand Name

MEDLINE

Version/Model Number

DYNDH1525

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

73b91d95-0a3d-48f5-ad89-018dd188f49c

Public Version Date

April 13, 2020

Public Version Number

1

DI Record Publish Date

April 03, 2020

Package DI Number

20193489190523

Quantity per Package

50

Contains DI Package

10193489190526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE