Catalog Number

-

Brand Name

NAZORCAP Sampler

Version/Model Number

Model No. 9801-F4

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)

Yes

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

210d3fa2-44f6-44ee-aa85-eecff3f2014c

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

February 08, 2016

Package DI Number

10856824006066

Quantity per Package

25

Contains DI Package

00856824006069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box