AccessGUDID - DEVICE: TRUWAVE (07460691957640)

GUDID

Device Identifier (DI) Information

Brand Name: TRUWAVE
Version or Model: MK2458
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MK2458
Company Name: Edwards Lifesciences LLC

Primary DI Number: 07460691957640
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: 4 PORT CONNECTOR STERILE

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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
Intravenous line/syringe Luer connector, sterile	A sterile device intended to be used to assemble an intravenous (IV) fluid line by connecting tubing, stopcocks, adaptors/connectors, and syringes to the IV line; it may also be used to connect a syringe to a vial adaptor. It has a Luer connection (slip or lock) at each end and may incorporate features to prevent leakage (drip-lock), egress, and ingress of materials (i.e., hazardous drugs, microbes) or minimize the potential of aerosolization; it does not contain a valve mechanism or closed pressure equalization chamber. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Intravenous line/syringe Luer connector, sterile

A sterile device intended to be used to assemble an intravenous (IV) fluid line by connecting tubing, stopcocks, adaptors/connectors, and syringes to the IV line; it may also be used to connect a syringe to a vial adaptor. It has a Luer connection (slip or lock) at each end and may incorporate features to prevent leakage (drip-lock), egress, and ingress of materials (i.e., hazardous drugs, microbes) or minimize the potential of aerosolization; it does not contain a valve mechanism or closed pressure equalization chamber. 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
No Device Sizes

Device Record Status

Public Device Record Key: 311998ff-2600-493d-9abf-e6170843a28a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 03, 2016