Catalog Number

BELL-82500-A

Brand Name

ProGen Phlebotomy Kit

Version/Model Number

BELL-82500-A

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

9028beb5-b581-4da2-aead-f1e167720f57

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 15, 2017

Package DI Number

10861122000333

Quantity per Package

100

Contains DI Package

00861122000336

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper