Diagnostic Station DS20 3.930525

GUDID 07613365000481

The Diagnostic Station DS20 is a 3-lead ECG device that is intended for use in the recording, analysis and evaluation of ECG waveforms. The DS20 is al

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 ID07613365000481
NIH Device Record Keyeda7d301-9130-40e7-bdfe-a470a566fb96
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiagnostic Station DS20
Version Model Number3.930525
Catalog Number3.930525
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 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
GS107613365000481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide

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 Date2016-09-19

On-Brand Devices [Diagnostic Station DS20]

07613365000498The Diagnostic Station DS20 is a 12-lead ECG device that is intended for use in the recording, a
07613365000481The Diagnostic Station DS20 is a 3-lead ECG device that is intended for use in the recording, an
07613365000474The Diagnostic Station DS20 is a 12-lead ECG device that is intended for use in the recording, a
07613365000467The Diagnostic Station DS20 is a 3-lead ECG device that is intended for use in the recording, an
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