Catalog Number

27678

Brand Name

DISP NK COMP SPO2 SNSR,TL-273T,39",EA

Version/Model Number

CSA027DN-M100

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

3654bc4b-348b-4eee-8b76-e39ba29a4353

Public Version Date

April 08, 2022

Public Version Number

1

DI Record Publish Date

March 31, 2022

Package DI Number

10840828185773

Quantity per Package

30

Contains DI Package

00840828185776

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case