Catalog Number

PHX-1001

Brand Name

Phoenix Healthcare Solutions LLC

Version/Model Number

PHX-1001

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"

-

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

FMK

Product Code Name

Lancet, Blood

Public Device Record Key

f93acf53-d443-4ba6-8c92-5ac2ab057152

Public Version Date

September 24, 2021

Public Version Number

1

DI Record Publish Date

September 16, 2021

Package DI Number

10360913010013

Quantity per Package

100

Contains DI Package

00360913010016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE