Catalog Number

HA902-1400

Brand Name

Pointe Scientific, Inc.

Version/Model Number

HA902-1400

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K822471

Product Code

CIX

Product Code Name

Bromcresol Green Dye-Binding, Albumin

Public Device Record Key

d19daeab-d0f0-4565-a7fd-fab7bf7b76e7

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-