DALTON BLOOD PRESSURE MONITOR - AUTOMATIC-INFLATION ELECTRIC METER, PORTABLE, ARM - DALTON MEDICAL CORPORATION

Duns Number:874709348

Device Description: AUTOMATIC-INFLATION ELECTRIC METER, PORTABLE, ARM TYPE. ADULT CUFF.

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More Product Details

Catalog Number

-

Brand Name

DALTON BLOOD PRESSURE MONITOR

Version/Model Number

BPM-DI2002A

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"

-

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

-

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

12358415-de0d-4364-8a01-9a514c2f2fdb

Public Version Date

October 11, 2021

Public Version Number

5

DI Record Publish Date

September 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DALTON MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 66
2 A medical device with a moderate to high risk that requires special controls. 57