CARDIOVIT® AT-101 3.920963

GUDID 07613365000078

The CARDIOVIT® AT-101 is a 12-lead ECG device used for the recording, analysis and evaluation of ECG recordings.

Schiller AG

Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel
Primary Device ID07613365000078
NIH Device Record Key36ecbaac-4600-4e4e-a306-30fa6c4dbe81
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARDIOVIT® AT-101
Version Model Number3.920963
Catalog Number3.920963
Company DUNS480868538
Company NameSchiller AG
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 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 TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 25 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613365000078 [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 Date2020-02-17
Device Publish Date2016-09-18

On-Brand Devices [CARDIOVIT® AT-101]

07613365000078The CARDIOVIT® AT-101 is a 12-lead ECG device used for the recording, analysis and evaluation o
07613365000061The CARDIOVIT® AT-101 is a 12-lead ECG device used for the recording, analysis and evaluation o

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.