Catalog Number

0010391.000

Brand Name

CUVETTES DC-80 Box 100 cuvettes & 100 plugs

Version/Model Number

Cuvette/Plug Kit

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

4f1915e7-f156-4e09-8a7c-ca7f7fc2d81c

Public Version Date

March 21, 2019

Public Version Number

3

DI Record Publish Date

February 12, 2017

Package DI Number

0034791000

Quantity per Package

3

Contains DI Package

B154O00103910003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Half Case