Indie Health 51-1490

GUDID 00845717008099

Digital Blood Pressure Monitor - Arm with Bluetooth

VERIDIAN HEALTHCARE LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID00845717008099
NIH Device Record Key3d34acfb-b046-45a9-9f6a-e28c1fa96bf6
Commercial Distribution StatusIn Commercial Distribution
Brand NameIndie Health
Version Model Number51-1490
Catalog Number51-1490
Company DUNS830437997
Company NameVERIDIAN HEALTHCARE LLC
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100845717008099 [Primary]
GS110845717008096 [Package]
Package: Master Carton [10 Units]
In Commercial Distribution

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 Number3
Public Version Date2019-11-08
Device Publish Date2017-01-19

Devices Manufactured by VERIDIAN HEALTHCARE LLC

10845717011010 - Veridian Healthcare2024-09-18 SmartHeart Arm Blood Pressure Monitor
10845717011027 - Veridian Healthcare2024-09-18 SmartHeart Wrist Blood Pressure Monitor
00845717000215 - Veridian Healthcare2024-09-04 Heritage Series Aneroid Sphygmomanometer
00845717000222 - Veridian Healthcare2024-09-04 Heritage Latex-Free Aneroid Sphygmomanometer, Large Adult
10845717000236 - Veridian Healthcare2024-09-04 Heritage Latex-Free Aneroid Sphygmomanometer, Child
00845717010733 - TherraCare2022-12-13 TheraCare Deep Tissue Massager
30845717009202 - SmartHeart2022-08-31 SmartHeart Auto Digital BP Monitor, Wide Range Cuff
00810028770089 - Fridababy2021-07-19 Fridababy Bulb Rectal Thermometer

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