Holter Prep Kit

GUDID 30812345026024

Holter prep kit with AAA battery cleared with H3+ Holter recorder

MORTARA INSTRUMENT, INC.

Electrocardiographic ambulatory recorder
Primary Device ID30812345026024
NIH Device Record Key53ae5108-ee3d-42a2-81b8-d14f6f6eeaa9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHolter Prep Kit
Version Model NumberXKTHOLT5LA
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from heat
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110812345026020 [Primary]
GS120812345026027 [Package]
Contains: 10812345026020
Package: [10 Units]
In Commercial Distribution
GS130812345026024 [Package]
Contains: 20812345026027
Package: [3 Units]
In Commercial Distribution

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 Number6
Public Version Date2020-06-29
Device Publish Date2016-09-24

On-Brand Devices [Holter Prep Kit]

10812345029939Holter prep kit with AA battery cleared with Vision 5LR recorder
30812345026024Holter prep kit with AAA battery cleared with H3+ Holter recorder

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