Catalog Number

-

Brand Name

Disposable Infant Color-coded

Version/Model Number

S1-0683-14-0001-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

614a8ffe-48e7-48e3-9097-c792e9145f96

Public Version Date

May 12, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

06944904098845

Quantity per Package

10

Contains DI Package

06944904060231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-