Actiheart 08-305

GUDID B329AH420

Ambulatory ECG recorder with acclerometer - single channel

CAMNTECH LIMITED

Telemetric electrocardiographic ambulatory recorder
Primary Device IDB329AH420
NIH Device Record Key96e75109-6645-4035-ba26-c2651f598f6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameActiheart
Version Model NumberAH4
Catalog Number08-305
Company DUNS399114941
Company NameCAMNTECH LIMITED
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 830-755-8036
Emailsales@camntech.com
Phone+1 830-755-8036
Emailsales@camntech.com
Phone+1 830-755-8036
Emailsales@camntech.com
Phone+1 830-755-8036
Emailsales@camntech.com
Phone+1 830-755-8036
Emailsales@camntech.com
Phone+1 830-755-8036
Emailsales@camntech.com
Phone+1 830-755-8036
Emailsales@camntech.com
Phone+1 830-755-8036
Emailsales@camntech.com
Phone+1 830-755-8036
Emailsales@camntech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB329AH420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWKConditioner, Signal, Physiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-09-24

On-Brand Devices [Actiheart]

B329AH420Ambulatory ECG recorder with acclerometer - single channel
B329AHBT56Ambulatory ECG recorder with acclerometer - single channel
B329AH556Ambulatory ECG recorder with acclerometer - single channel

Trademark Results [Actiheart]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACTIHEART
ACTIHEART
76472072 3016645 Live/Registered
CAMNTECH LIMITED
2002-11-29

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