Catalog Number

02K9112

Brand Name

ARCHITECT

Version/Model Number

2K91-12

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

K052000

Product Code

JIT

Product Code Name

CALIBRATOR, SECONDARY

Public Device Record Key

5ff9f6fd-5d78-4f24-b7b9-ad53eb38761a

Public Version Date

June 22, 2020

Public Version Number

4

DI Record Publish Date

May 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-