Catalog Number

0640210

Brand Name

Calibration Gas

Version/Model Number

0640210

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

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

-

Product Code

DPZ

Product Code Name

Oximeter, ear

Public Device Record Key

a9abdf2e-b901-4f4d-8ada-4b1f3b60db3d

Public Version Date

November 27, 2020

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

05700693095288

Quantity per Package

6

Contains DI Package

15700693095285

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-