Catalog Number

-

Brand Name

BlackBox RPM

Version/Model Number

PO-401W

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K120502,K120502

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

74eb60f4-4dc4-4af2-9526-6862ff02b877

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

October 20, 2020

Package DI Number

BB4B963PO401W1

Quantity per Package

136

Contains DI Package

B963PO401W1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cartons