Catalog Number

11-50L

Brand Name

SmartHeart

Version/Model Number

11-50L

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

-

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

4ce0e390-14c4-453f-ae70-d7db42f0dc2f

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

May 02, 2019

Package DI Number

10845717006818

Quantity per Package

24

Contains DI Package

30845717006812

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Shipper