Catalog Number

26413

Brand Name

SPO2 AD CB, PHILIPS 8-PIN NELLC0R OXM,6"

Version/Model Number

CB-A400-0604

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

Yes

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

K182220

Product Code

DSA

Product Code Name

Cable, Transducer And Electrode, Patient, (Including Connector)

Public Device Record Key

413e8e0e-e3df-4449-b297-397e3799d0c2

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

October 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-