DEVICE: WorkMate™ (05415067001160)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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? |
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37807 | Cardiac catheterization monitoring system |
An assembly of devices designed to continuously obtain, amplify, and record various signals generated during procedures usually performed in the cardiac catheterization laboratory. It typically consists of a computerized central workstation including a monitor and a graphic recorder, and a slave monitor including patient interface modules in the catheterization laboratory. The system is used for procedures such as left heart catheterization, right heart catheterization ventriculograms, coronary angiography, and pacemaker insertions; also used in procedures intended for the determination of most haemodynamic characteristics, evaluation of therapies, and planning of surgical approaches.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K132073 | 000 |
K210392 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep Dry. Do not use if package is damaged. |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Handling Environment Temperature: between -20 and 60 Degrees Celsius |
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8021922f-62e0-4a7a-b2e7-5e15870fe91c
October 26, 2023
5
March 28, 2016
October 26, 2023
5
March 28, 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 |
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No Package DIs found |
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
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com