Schiller ECG patient cable 2.400201

GUDID 07613365003604

ECG LP C 3.0 x5 IEC

Schiller AG

Electrocardiographic lead set, reusable
Primary Device ID07613365003604
NIH Device Record Key4a2fb769-8d18-40ad-a6c7-ea8f72d220f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSchiller ECG patient cable
Version Model Number2.400201
Catalog Number2.400201
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
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
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
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch
Phone+41417664242
Emailinfo@schiller.ch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107613365003604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSACable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-05
Device Publish Date2023-09-27

On-Brand Devices [Schiller ECG patient cable]

07613365001990ECG 10-wire patient cable IEC banana plug 2.1 m
07613365001983ECG 10- wire patient cable IEC dot clip 2.1 m
07613365001976ECG 10-wire patient cable AHA banana plug 2.1 m
07613365001969ECG 10-wire patient cable AHA dot clip 2.1 m
07613365001808ECG 10-wire patient cable IEC banana plug 2.0 m
07613365001792ECG 3-wire patient cable IEC clip 3.0 m
07613365001785ECG 5-wire patient cable AHA dot clip 3.0 m
07613365001778ECG 3-wire patient cable IEC dot clip 3.0 m
07613365001761ECG 10-wire patient cable IEC clip 3.5 m
07613365001754ECG 10-wire patient cable IEC banana plug 2.0 m
07613365000450ECG 10-wire patient cable AHA Non-LP clip 3.0 m
07613365000269ECG 10-wire patient cable AHA LP clip 3.0 m
07613365000252ECG 10-wire patient cable AHA LP clip 3.5 m
07613365000238ECG 10-wire patient cable AHA banana plug 3.5 m
07613365000221ECG 10-wire patient cable AHA clip 3.5 m
07613365000214ECG 10-wire patient cable AHA clip 3.5 m
07613365000207ECG 10-wire patient cable AHA banana plug 3.1 m
07613365001952ECG 5-wire patient cable, medilogAR 0.8 m
07613365001945ECG 7-wire patient cable, medilogAR 0.8 m
07613365002225ECG D-SUB B 2.0 x10 AHA 10-wire patient cable AHA, banana plug, 2m
07613365002218ECG D-SUB C 3.5 x10 AHA 10-wire patient cable AHA, clip-type, 3.5m
07613365003215ECG D-SUB B 2.4 x14 AHA 14-wire patient cable AHA, banana plug, 3.5m with detachable single lead
07613365003208ECG D-SUB C 2.4 x14 IEC 14-wire patient cable IEC, clip type, 3.5m with detachable single leads
07613365002874ECG D-SUB B 2.4 x14 IEC 14-wire patient cable IEC, banana plug, 3.5m with detachable single lead
07613365000245ECG D-SUB C 2.4 x14 AHA 14-wire patient cable AHA, clip type, 3.5m with detachable single leads
07613365003604ECG LP C 3.0 x5 IEC

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