AccessGUDID - DEVICE: TRUWAVE (07460691954304)

GUDID

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Device Identifier (DI) Information

Brand Name: TRUWAVE
Version or Model: PXMK573
Catalog Number: PXMK573
Company Name: Edwards Lifesciences LLC

Primary DI Number: 07460691954304
Issuing Agency: GS1
Device Count: 1

Device Description: PRESSURE MONITORING KIT - STERILE

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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.

FDA Product Code

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Product Code	Product Code Name
DXO	TRANSDUCER, PRESSURE, CATHETER TIP

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE.

Clinically Relevant Size

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

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 03, 2016
Commercial Distribution End Date:

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
57460691954309	20	07460691954304		In Commercial Distribution	Shipper

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: TRUWAVE (07460691954304)