Qardio Pro Cellular Blood Pressure Monitor BP100-4G

GUDID 10854894005392

Pro Cellular Blood Pressure Monitor

QARDIO, INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID10854894005392
NIH Device Record Keyed1b7e6b-54b7-4ab9-bedc-b4e801b08c44
Commercial Distribution StatusIn Commercial Distribution
Brand NameQardio Pro Cellular Blood Pressure Monitor
Version Model NumberBP100-4G
Catalog NumberBP100-4G
Company DUNS080029958
Company NameQARDIO, 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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100854894005395 [Primary]
GS110854894005392 [Package]
Contains: 00854894005395
Package: [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-07
Device Publish Date2021-11-29

Devices Manufactured by QARDIO, INC.

10854894005347 - QardioArm22023-06-27
10854894005354 - QardioArm22023-06-27
10854894005392 - Qardio Pro Cellular Blood Pressure Monitor2021-12-07Pro Cellular Blood Pressure Monitor
10854894005392 - Qardio Pro Cellular Blood Pressure Monitor2021-12-07 Pro Cellular Blood Pressure Monitor
10854894005415 - Qardio Pulse Oximeter2021-01-21
10854894005422 - Qardio Forehead thermometer2021-01-18
00854894005005 - QardioArm2019-11-08
00854894005012 - QardioArm2019-11-08
00854894005029 - QardioArm2019-11-08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.