Caring Mill - Upper Arm Digital Blood Pressure Monitor with - Caring Mill

Duns Number:049283340

Device Description: Upper Arm Digital Blood Pressure Monitor with Adjustable Cuff

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More Product Details

Catalog Number

656.70

Brand Name

Caring Mill

Version/Model Number

BEUBM31

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

Yes

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 Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

f4652d34-143a-47c7-9f59-26609f59ceb1

Public Version Date

November 10, 2020

Public Version Number

1

DI Record Publish Date

November 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARING MILL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16