Catalog Number

06K4704

Brand Name

ARCHITECT

Version/Model Number

06K4704

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

K050613

Product Code

JJS

Product Code Name

Controls for blood-gases, (assayed and unassayed)

Public Device Record Key

4e2da0f8-f2e2-4604-aa03-3e4e20b2e7d9

Public Version Date

October 10, 2022

Public Version Number

2

DI Record Publish Date

March 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-