Catalog Number

-

Brand Name

CM-1500 Wrist Cuff

Version/Model Number

700460

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191697

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

6955db89-95dd-47fb-9f5a-532509c2e949

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

January 28, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-