DALTON BLOOD PRESSURE MONITOR

GUDID 00815027010006

NON-INVASIVE BLOOD PRESSURE MONITOR, WRIST TYPE.

DALTON MEDICAL CORPORATION

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID00815027010006
NIH Device Record Key4448ade7-4890-4717-856e-360711b0ab7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDALTON BLOOD PRESSURE MONITOR
Version Model NumberBPM-DI2003R
Company DUNS874709348
Company NameDALTON MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS100815027010006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-09-18

On-Brand Devices [DALTON BLOOD PRESSURE MONITOR]

00815027010020AUTOMATIC-INFLATION ELECTRIC METER, PORTABLE, ARM TYPE. ADULT LARGE CUFF.
00815027010013AUTOMATIC-INFLATION ELECTRIC METER, PORTABLE, ARM TYPE. ADULT CUFF.
00815027010006NON-INVASIVE BLOOD PRESSURE MONITOR, WRIST TYPE.

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