CARDIOVIT® FT-1 3.900864

GUDID 07613365002003

The CARDIOVIT® FT-1 is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings.

Schiller AG

Electrocardiograph, professional, multichannel
Primary Device ID07613365002003
NIH Device Record Keyc67bf981-0414-42f5-bbcb-67efd1db2c7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARDIOVIT® FT-1
Version Model Number3.900864
Catalog Number3.900864
Company DUNS480868538
Company NameSchiller AG
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 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+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613365002003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-09-08

On-Brand Devices [CARDIOVIT® FT-1]

07613365002003The CARDIOVIT® FT-1 is a 12-lead ECG device used for the recording, analysis and evaluation of
07613365003642The CARDIOVIT® FT-1 is a 12-lead ECG device used for the recording, analysis and evaluation of

Trademark Results [CARDIOVIT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARDIOVIT
CARDIOVIT
76508787 2855699 Live/Registered
Schiller Holding AG
2003-04-23
CARDIOVIT
CARDIOVIT
73810989 1596212 Dead/Cancelled
SCHILLER AMERICA, INC.
1989-07-06

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