ECG Cable for SEER 1000 2104822-001

GUDID 04250903201691

The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder).

getemed Medizin- und Informationstechnik AG

Electrocardiographic lead set, reusable
Primary Device ID04250903201691
NIH Device Record Keybb0134f1-c5a6-4037-b333-df311f9b6873
Commercial Distribution StatusIn Commercial Distribution
Brand NameECG Cable for SEER 1000
Version Model Number3 Leads, 105 cm, AHA Color Code
Catalog Number2104822-001
Company DUNS331682898
Company Namegetemed Medizin- und Informationstechnik 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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de
Phone+49332939420
Emailinfo@getemed.de

Operating and Storage Conditions

Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104250903201691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWJElectrocardiograph,Ambulatory(Without Analysis)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-20
Device Publish Date2019-09-12

On-Brand Devices [ECG Cable for SEER 1000]

04250903201691The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903201684The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903201677The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903201660The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903201653The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903201646The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903201639The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903201622The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903201615The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903201608The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903201592The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
04250903201585The cable is intended to be used to conduct electrical signals from a patient's heart, via an el
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.