Catalog Number

-

Brand Name

Greater Goods

Version/Model Number

0003

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151206,K151206

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

9983afc0-df4e-4e51-8d0e-b82d113a65fb

Public Version Date

January 26, 2022

Public Version Number

1

DI Record Publish Date

January 18, 2022

Package DI Number

10875011000038

Quantity per Package

100

Contains DI Package

00875011000031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton