DEVICE: Wi-Box™ (05414734054164)

Device Identifier (DI) Information

Wi-Box™
PSU Kit
In Commercial Distribution
C12785
ST. JUDE MEDICAL, INC.
05414734054164
GS1

1
149818952 *Terms of Use
Cable
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electrical mains power cable An insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
DRG TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Special Storage Condition, Specify: Store at room temperature in a dry place. Do not use if package is damaged.
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

8b3ada72-9697-49f4-adab-f85770a41354
March 29, 2018
2
March 16, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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