H3+ Patient Cable

GUDID 00812345024999

Patient cable cleared with H3+ recorder

MORTARA INSTRUMENT, INC.

Electrocardiographic lead set, reusable
Primary Device ID00812345024999
NIH Device Record Key838c53b3-90b4-429c-ad55-098bc7449659
Commercial Distribution StatusIn Commercial Distribution
Brand NameH3+ Patient Cable
Version Model Number9293-036-52
Company DUNS062046149
Company NameMORTARA INSTRUMENT, INC.
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com
Phone888-667-8272
Emailtechsupport@mortara.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100812345024999 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-06-29
Device Publish Date2016-09-24

On-Brand Devices [H3+ Patient Cable]

00812345025064Patient cable cleared with H3+ recorder
00812345025057Patient cable cleared with H3+ recorder
00812345025040Patient cable cleared with H3+ recorder
00812345025033Patient cable cleared with H3+ recorder
00812345025026Patient cable cleared with H3+ recorder
00812345025002Patient cable cleared with H3+ recorder
00812345024999Patient cable cleared with H3+ recorder
00812345024982Patient cable cleared with H3+ recorder
00812345023084Patient cable cleared with H3+ recorder
00812345023077Patient cable cleared with H3+ recorder

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