Catalog Number

2100-2OR

Brand Name

Diagnostix™

Version/Model Number

2100-2OR

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101577,K101577,K101577

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

a6a31d36-e2f2-4b71-9a42-2dd513b54ad2

Public Version Date

November 10, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

00634782562854

Quantity per Package

50

Contains DI Package

00634782862855

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case