Catalog Number

-

Brand Name

Surelife

Version/Model Number

860320

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"

Yes

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

K141105,K141105

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

b0cbebd9-061a-4b03-8a42-4e6afc3de0e2

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

January 22, 2018

Package DI Number

MHC18603203

Quantity per Package

10

Contains DI Package

MHC18603202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-