DEVICE: EnSite™ (05415067024831)
Device Identifier (DI) Information
EnSite™
H702483
In Commercial Distribution
H702483
ST. JUDE MEDICAL, INC.
H702483
In Commercial Distribution
H702483
ST. JUDE MEDICAL, INC.
Noise Reduction Transformer, 240V
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
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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? |
---|---|---|---|---|
16933 | Constant-voltage transformer |
A device designed to deliver a fixed, predetermined voltage that is one of a limited range of input voltage variations. The device receives a fluctuating input voltage and transforms this fluctuating voltage into a steady (constant) output helping to avoid such fluctuations which are present in the electrical system. These fluctuations may be known as spikes, and can be harmful to devices with sensitive electronics. This device may be inserted into new or existing electrical systems.
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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 [?] |
---|---|
K141050 | 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. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1f9d6499-d1eb-43fd-9d7c-56e43bf25199
July 31, 2023
4
December 07, 2016
July 31, 2023
4
December 07, 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 |
---|---|---|---|---|---|
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