XScribe Cardiopulmonary Kit

GUDID 00817655020068

Cardiac stress exercise monitoring system Cardiac stress exercise monitoring system

Primary Device ID	00817655020068
NIH Device Record Key	6284ed97-79c8-482c-879a-23dc1e5ded45
Commercial Distribution Status	In Commercial Distribution
Brand Name	XScribe Cardiopulmonary Kit
Version Model Number	41000-030-62
Company DUNS	062046149
Company Name	MORTARA INSTRUMENT, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 149 Degrees Fahrenheit

Device Issuing Agency	Device ID
GS1	00817655020068 [Primary]

DPS	Electrocardiograph

Steralize Prior To Use	false
Device Is Sterile	false

00817655021423	Cardiopulmonary accessory kit cleared with XScribe
00817655020068	Cardiopulmonary accessory kit cleared with XScribe
00817655020051	Cardiopulmonary accessory kit cleared with XScribe