DEVICE: TRUWAVE (07460691951587)

Device Identifier (DI) Information

TRUWAVE
MK2267
In Commercial Distribution
MK2267
Edwards Lifesciences LLC
07460691951587
GS1

1
134139174 *Terms of Use
PRESSURE TUBING
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Invasive blood pressure monitoring tubing set A collection of devices that includes the necessary tubing and other items, e.g., connectors, stopcock(s), clamps and filters, used as an external connection for invasive blood pressure measurement. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. 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

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Size Type Text
Length: 96 Inch
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Device Record Status

a6d56f38-c317-4f42-b619-b4be113e1363
July 06, 2018
3
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
57460691951582 20 07460691951587 In Commercial Distribution Shipper
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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

[?]
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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