DEVICE: QUANTIEN™ (05415067004659)

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Device Identifier (DI) Information

QUANTIEN™
Meaurement System
C12799
ST. JUDE MEDICAL, INC.
05415067004659
GS1
1
No description.
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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
Image display monitor mount A dedicated mount onto which a visual display unit (VDU), e.g., a patient monitor, can be placed and secured so that it is safely mounted in a position suitable for viewing. This device will provide for adequate vertical and horizontal adjustment possibilities and will be manufactured for hospital use. In some situations a television set may be mounted instead. It will typically be affixed to a wall, ceiling, or the top of, or into, a medical device or system.
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FDA Product Code

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Product Code Product Code Name
DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE
DSK COMPUTER, BLOOD-PRESSURE
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Sterilization

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

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Storage and Handling
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry. Do not use if package is damaged.
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Handling Environment Temperature: between -20 and 70 Degrees Celsius
Handling Environment Temperature: between -4 and 158 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
January 14, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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