HScribe

GUDID 00817655020365

Holter Analysis System

MORTARA INSTRUMENT, INC.

Electrocardiographic long-term ambulatory recording analyser application software
Primary Device ID00817655020365
NIH Device Record Key301a5a5a-65ce-490b-8e6d-f8281895b4e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHScribe
Version Model NumberHSCRIBE-6AC-XXXXB
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 HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100817655020365 [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 Date2016-10-17

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00812345029857Holter Analysis System
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00812345027280Holter Analysis System
00812345027273Holter Analysis System
00812345027266Holter Analysis System
00812345027259Holter Analysis System
00812345027242Holter Analysis System
00812345027235Holter Analysis System
00812345027228Holter Analysis System
00812345027211Holter Analysis System
00812345027204Holter Analysis System
00812345027198Holter Analysis System
00812345027181Holter Analysis System
00812345027174Holter Analysis System
00812345027167Holter Analysis System
00812345027150Holter Analysis System
00812345027143Holter Analysis System
00812345027136Holter Analysis System
00812345027129Holter Analysis System
00817655022635Holter Analysis System Software
00817655022529Holter Analysis System
00817655022512Holter Analysis System
00817655022505Holter Analysis System
00817655022499Holter Analysis System
00817655022482Holter Analysis System
00817655022284Holter Analysis System
00817655022277Holter Analysis System
00817655022260Holter Analysis System
00817655022239Holter Analysis System
00817655022161Holter Analysis System
00817655021904Holter Analysis System
00817655021829Holter Analysis System
00817655021744Holter Analysis System
00817655021461Holter Analysis System
00817655021102Holter Analysis System
00817655021096Holter Analysis System
00817655021089Holter Analysis System
00817655021072Holter Analysis System
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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