DEVICE: PressureWire™ (05415067000118)

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Device Identifier (DI) Information

PressureWire™
Receiver
C17040
ST. JUDE MEDICAL, INC.
05415067000118
GS1
1
Signal Receiver Kit
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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
Catheter-tip transducer, pressure A device that is incorporated into the distal end of a catheter to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results as pressure values. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DXO TRANSDUCER, PRESSURE, CATHETER TIP
DQX WIRE, GUIDE, CATHETER
DRG TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
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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
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -25 and 70 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry. Do not use if package is damaged.
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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
April 21, 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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No
Yes
No
Yes
No CLOSE

Customer Contact

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