Biotres Pro

GUDID B635BIOTRESPR0

BIOTRICITY INC

Electrocardiographic ambulatory recorder
Primary Device IDB635BIOTRESPR0
NIH Device Record Key00d78f05-5a14-4691-8fe5-974aa7d75b31
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiotres Pro
Version Model Number1.0
Company DUNS023227352
Company NameBIOTRICITY INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB635BIOTRESPR0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWJElectrocardiograph, Ambulatory (Without Analysis)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-15
Device Publish Date2024-03-07

Devices Manufactured by BIOTRICITY INC

B635BIOTRESPR0 - Biotres Pro2024-03-15
B635BIOTRESPR0 - Biotres Pro2024-03-15
B635BIOFLUX1A0 - BIOFLUX2022-09-08
B635BIOTRES100 - Biotricity2022-02-25
B635BIOFLUX101 - BIOFLUX2019-05-07

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