Catalog Number

A13-0068

Brand Name

Vasomedical™ EZ™ O2 Neonatal Probe (for children under 3 years of age)

Version/Model Number

Model EZ

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

K063641

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

628f7f58-247a-4356-81cb-27e06ac9c28a

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

November 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-