Catalog Number

06C0610

Brand Name

ARCHITECT

Version/Model Number

6C06-10

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

-

Product Code

JIS

Product Code Name

CALIBRATOR, PRIMARY

Public Device Record Key

0b056c03-6dbe-43a9-aa87-ec341d07685e

Public Version Date

February 06, 2020

Public Version Number

3

DI Record Publish Date

November 18, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-