Hello Heart

GUDID 00682891390592

BP Monitor UAM-905HH

ZEWA, INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID00682891390592
NIH Device Record Keyd6229475-cc62-49dc-8b3e-5c10e89aff6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHello Heart
Version Model NumberUAM-905HH
Company DUNS013481078
Company NameZEWA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100682891390592 [Primary]

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 Number2
Public Version Date2019-11-08
Device Publish Date2018-12-04

On-Brand Devices [Hello Heart]

00682891390592BP Monitor UAM-905HH
00682891390585BP Monitor UAM-905MH
00682891390608BP Monitor UAM-906HH

Trademark Results [Hello Heart]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HELLO HEART
HELLO HEART
88777699 not registered Live/Pending
Hello Heart Inc.
2020-01-29
HELLO HEART
HELLO HEART
86784510 4972564 Live/Registered
Hello Doctor, Ltd
2015-10-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.