AccessGUDID - DEVICE: TRUWAVE (07460691950061)

GUDID

Device Identifier (DI) Information

Brand Name: TRUWAVE
Version or Model: PX2X2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PX2X2
Company Name: Edwards Lifesciences LLC

Primary DI Number: 07460691950061
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

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
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.

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.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142749	000

Device Exempt from Premarket Submission: No CLOSE

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 Record Status

Public Device Record Key: dfe656b4-53b5-4291-8df8-2ffcf8979be5
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 03, 2016