Catalog Number

-

Brand Name

no

Version/Model Number

77553C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 15, 2019

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

OFM

Product Code Name

Phlebotomy blood collection kit

Public Device Record Key

52c5157e-f847-42e0-9001-c644caf6e28c

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

May 29, 2018

Package DI Number

20809160195700

Quantity per Package

20

Contains DI Package

10809160195703

Package Discontinue Date

March 15, 2019

Package Status

Not in Commercial Distribution

Package Type

-