BIOS Diagnostics

GUDID 20057475244105

Blood Pressure Monitor/Automatic AFIB

Thermor Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID20057475244105
NIH Device Record Key494e4d1d-755e-46d1-926c-eacaaf47e9b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOS Diagnostics
Version Model NumberBD410
Company DUNS246883458
Company NameThermor Ltd
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 Numberfalse
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
GS100057475244101 [Primary]
GS110057475244108 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS120057475244105 [Package]
Contains: 00057475244101
Package: Case [2 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 Date2024-02-06
Device Publish Date2024-01-29

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