AccessGUDID - DEVICE: TRUWAVE (07460691950061)

GUDID

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Device Identifier (DI) Information

Brand Name: TRUWAVE
Version or Model: PX2X2
Catalog Number: PX2X2
Company Name: Edwards Lifesciences LLC

Primary DI Number: 07460691950061
Issuing Agency: GS1
Device Count: 1

Device Description: PRESSURE MONITORING SET

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
Total Volume: 3 Milliliter

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
57460691950066	10	07460691950061		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 (07460691950061)