DEVICE: TRUWAVE (07460691954304)

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Device Identifier (DI) Information

TRUWAVE
PXMK573
PXMK573
Edwards Lifesciences LLC
07460691954304
GS1
1
PRESSURE MONITORING KIT - STERILE
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Blood pressure transducer, single-use A sterile, noninvasive electronic device intended to convert pressure into electrical signals for the invasive measurement of blood pressure. It is a small housing intended to be connected to invasive vascular access device(s) [e.g., needle, catheter] and will either include a display or be intended to be connected to an independent patient monitoring system; it may include a guidewire access port. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DXO TRANSDUCER, PRESSURE, CATHETER TIP
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: TOTAL VOLUME: 3 CC, LENGTH: 72 INCH (180 CENTIMETER)
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Device Status

In Commercial Distribution
September 03, 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
57460691954309 20 07460691954304 In Commercial Distribution Shipper
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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
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)822-9637
tech_support@edwards.com
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