Catalog Number

27091

Brand Name

DISP NLCR COMPAT SPO2 SNSR, OXMX,SC-A

Version/Model Number

CSA001DN-E200

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,K182220

Product Code

DSA

Product Code Name

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

Public Device Record Key

8fe4c0bc-c728-4c96-a402-8d3c03fd63bd

Public Version Date

January 25, 2022

Public Version Number

4

DI Record Publish Date

August 07, 2020

Package DI Number

10840828180600

Quantity per Package

30

Contains DI Package

00840828180603

Package Discontinue Date

September 15, 2021

Package Status

Not in Commercial Distribution

Package Type

-