Cura Bluetooth Blood Pressure Monitor LS810-B

GUDID 00843511100711

OMNIA MEDICAL, LLC

Patient monitoring system module, blood pressure, noninvasive
Primary Device ID00843511100711
NIH Device Record Keyf34ca9ed-1d2e-41e9-ba5d-e777da5ceef6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCura Bluetooth Blood Pressure Monitor
Version Model NumberLS810-B
Catalog NumberLS810-B
Company DUNS079467378
Company NameOMNIA MEDICAL, 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 Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3044134851
Emailcustomerservice@omniamedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100843511100711 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-06
Device Publish Date2020-02-27

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