XScribe Cardiopulmonary Kit

GUDID 00817655020051

Cardiopulmonary accessory kit cleared with XScribe

MORTARA INSTRUMENT, INC.

Cardiac stress exercise monitoring system
Primary Device ID00817655020051
NIH Device Record Keyff40c715-00b8-4669-93b0-d70b7fcf4732
Commercial Distribution StatusIn Commercial Distribution
Brand NameXScribe Cardiopulmonary Kit
Version Model Number41000-030-60
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 149 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 149 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817655020051 [Primary]

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-06-29
Device Publish Date2016-09-24

On-Brand Devices [XScribe Cardiopulmonary Kit]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.