HScribe

GUDID 00812345027334

Holter Analysis System

MORTARA INSTRUMENT, INC.

Electrocardiographic long-term ambulatory recording analyser application software Electrocardiographic long-term ambulatory recording analyser application software
Primary Device ID00812345027334
NIH Device Record Keyca6a6e6d-6954-4eb2-b609-4a7399009dda
Commercial Distribution StatusIn Commercial Distribution
Brand NameHScribe
Version Model NumberHSCRIBE-6AC-XXXXX
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 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
GS100812345027334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLOElectrocardiograph, Ambulatory, With Analysis Algorithm

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 Date2017-02-03

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00812345027266Holter Analysis System
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00812345027204Holter Analysis System
00812345027198Holter Analysis System
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00817655022277Holter Analysis System
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00817655021744Holter Analysis System
00817655021461Holter Analysis System
00817655021102Holter Analysis System
00817655021096Holter Analysis System
00817655021089Holter Analysis System
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00817655020716Holter Analysis System
00817655020655Holter Analysis System
00817655020570Holter Analysis System
00817655020563Holter Analysis System
00817655020426Holter Analysis System
00817655020396Holter Analysis System
00817655020389Holter Analysis System
00817655020372Holter Analysis System
00817655020365Holter Analysis System
00817655020228Holter Analysis System

Trademark Results [HScribe]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HSCRIBE
HSCRIBE
97885126 not registered Live/Pending
Welch Allyn, Inc.
2023-04-12
HSCRIBE
HSCRIBE
74376623 1827359 Live/Registered
MORTARA INSTRUMENT, INC.
1993-04-08
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