Catalog Number

PX-132-HP

Brand Name

HoMedics

Version/Model Number

PX-132-HP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K141105,K141105

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

2069cf65-ae7a-4d2e-8c6d-d20c8ef1a532

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

July 03, 2020

Package DI Number

10031262099287

Quantity per Package

100

Contains DI Package

00031262099280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case