DEVICE: TRUWAVE (07460691950719)

Device Identifier (DI) Information

TRUWAVE
PX2X2YB
In Commercial Distribution
PX2X2YB
Edwards Lifesciences LLC
07460691950719
GS1

1
134139174 *Terms of Use
PRESSURE MONITORING SET
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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
Invasive-pressure external transducer, single-use A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K142749 000
No CLOSE

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
Total Volume: 3 Milliliter
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Device Record Status

98c786c5-629e-446e-9ec5-f4922b6a9a19
July 06, 2018
4
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
57460691950714 10 07460691950719 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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