Catalog Number

27078

Brand Name

DISP NLCR COMPAT SPO2 SNSR,OXMX,MAX-I

Version/Model Number

CSA001DI-M300

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

31f053d1-56d9-4ceb-a7d8-0d3255da7c10

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

September 15, 2021

Package DI Number

10840828184202

Quantity per Package

30

Contains DI Package

00840828184205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE