Catalog Number

-

Brand Name

SANTAMEDICAL

Version/Model Number

SM-ACLED150

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180685,K180685

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

ad2f50f1-8fcc-4689-a95b-324abe689bea

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

June 01, 2020

Package DI Number

10810053630010

Quantity per Package

100

Contains DI Package

00810053630013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-