Catalog Number

-

Brand Name

NAZORCAP Sampler

Version/Model Number

Model No. 9801-M4

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K911970,K911970,K911970

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

da3f0c07-8696-4ab1-b1ae-97f429fbb19a

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

January 12, 2017

Package DI Number

40856824006067

Quantity per Package

100

Contains DI Package

30856824006060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case