Catalog Number

-

Brand Name

Caring Mill

Version/Model Number

MD300C29

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

Yes

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

OCH

Product Code Name

Oximeter, Infrared, Sporting, Aviation

Public Device Record Key

4125fb9d-cc30-4a4f-a43b-9a530aeaedf4

Public Version Date

June 21, 2019

Public Version Number

1

DI Record Publish Date

June 13, 2019

Package DI Number

10854875008206

Quantity per Package

240

Contains DI Package

00854875008209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton