Decipher Holter Monitor

GUDID 00862887000364

Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.

MEDICOMP, INC.

Electrocardiographic ambulatory recorder
Primary Device ID00862887000364
NIH Device Record Keydc5b2ce0-c95a-496b-8e64-5c4a4a87ed8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDecipher Holter Monitor
Version Model NumberPM461
Company DUNS057729253
Company NameMEDICOMP, 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

Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com
Phone8002343278
Emailinfo@medicompinc.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100862887000364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXHTransmitters And Receivers, Electrocardiograph, Telephone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-11-16

Devices Manufactured by MEDICOMP, INC.

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00862887000357 - Cardiac Monitor2019-11-08 Cardiac Monitor PM500 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are ex
00862887000364 - Decipher Holter Monitor2019-11-08Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia.
00862887000364 - Decipher Holter Monitor2019-11-08 Decipher Holter Monitor is a small, patient worn device, prescribed by physicians for patients who are experiencing symptoms tha
00862887000371 - TelePatch Cardiac Monitor2019-11-08 TelePatch CM PM700 is a small, auto triggered, or patient activated, device, prescribed by physicians for patients who are exper

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