Catalog Number

-

Brand Name

FaceLake

Version/Model Number

CMS-50EW with Bluetooth

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141362

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

9399b725-9011-433d-b0c5-4ecf05a34866

Public Version Date

November 10, 2021

Public Version Number

4

DI Record Publish Date

October 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-