DEVICE: Holter Prep Kit (10812345029939)
Device Identifier (DI) Information
Holter Prep Kit
043272
In Commercial Distribution
MORTARA INSTRUMENT, INC.
043272
In Commercial Distribution
MORTARA INSTRUMENT, INC.
Holter prep kit with AA battery cleared with Vision 5LR recorder
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35162 | Electrocardiographic ambulatory recorder |
An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQK | Computer, Diagnostic, Programmable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K945985 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep away from heat |
Storage Environment Temperature: less than 80 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
28a983cd-0fc7-4e14-9db2-ee264ad76fa3
June 29, 2020
5
September 24, 2016
June 29, 2020
5
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20812345029936 | 10 | 10812345029939 | In Commercial Distribution | ||
30812345029933 | 3 | 20812345029936 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
888-667-8272
techsupport@mortara.com
techsupport@mortara.com