TRUWAVE PXMK1390

GUDID 07460691953215

PRESSURE MONITORING KIT - STERILE

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

• Primary Device ID: 07460691953215
• NIH Device Record Key: d77fdc3c-abc3-4c75-b00d-6daca9d52a00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRUWAVE
• Version Model Number: PXMK1390
• Catalog Number: PXMK1390
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Total Volume: 3 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07460691953215 [Primary]
GS1	57460691953210 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142749

FDA Product Code

• DXO: TRANSDUCER, PRESSURE, CATHETER TIP

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-03

On-Brand Devices [TRUWAVE]

• 00690103197754: PRESSURE MONITORING SET
• 00690103197747: PRESSURE MONITORING SET
• 00690103197730: PRESSURE MONITORING SET
• 00690103196948: CABLE ASSY, TRUWAVE EMAGEON
• 00690103196863: CABLE ASSY,EW,TRI,SPLBS
• 00690103196856: CABLE ASSY,EW,BI,SPLBS
• 00690103196849: CABLE ASSY, TRUWAVE
• 00690103196832: CABLE ASSY, TRUWAVE
• 00690103196825: CABLE ASSY,EW,TRI,GE,ROHS
• 00690103196818: CABLE ASSY,EW,BI,GE, ROHS
• 00690103196795: CABLE ASSY, TRUWAVE
• 00690103196764: CABLE ASSY,EW,TRI,DATEX
• 00690103196757: CABLE ASSY,EW,BI,DATEX
• 00690103196740: CABLE ASSY,EW,TRI,PHLPS
• 00690103196733: CABLE ASSY,EW,BI,PHLPS
• 00690103196726: CABLE ASSY, TRUWAVE
• 00690103196719: CABLE ASSY, TRUWAVE
• 00690103196702: CABLE ASSY, TRUWAVE
• 00690103196696: CABLE ASSY, TRUWAVE
• 00690103196689: CABLE ASSY,EW,TRI,DSCPE
• 00690103196672: CABLE ASSY,EW,BI,DSCPE
• 00690103196665: CABLE ASSY,TRUWAVE
• 00690103196658: CABLE ASSY, TRUWAVE
• 00690103196641: CABLE ASSY, TRUWAVE, ROHS
• 00690103196634: CABLE ASSY,TRUWAVE
• 00690103196627: CABLE ASSY,EW TRUWAVE
• 00690103196610: CABLE ASSY, TRUEWAVE
• 00690103196603: CABLE ASSEMBLY,EW
• 00690103196597: CABLE ASSY,TRUWAVE
• 00690103196580: CABLE ASSY, EW QUEST ANTEGRADE
• 00690103196573: CABLE ASSY,EW QUEST RETROGRADE
• 00690103196566: CABLE ASSY,EW TRUWAVE
• 00690103196559: CABLE, ADAPTER, JOSTRA
• 00690103196542: CABLE ASSY,EW TRUWAVE
• 00690103196535: CABLE ASSY,EW TRUWAVE
• 00690103196528: CABLE ASY,EW HELLIGE 6 PIN PPG
• 00690103196511: CABLE ASSY,EW 10 PIN/DRAGER
• 00690103196504: CABLE ASSY,TRUWAVE
• 00690103196498: CABLE ASSY,EW PRUCKA
• 00690103196481: CBL ASY,EW 12 PN/FUKUDA DENSHI
• 00690103196474: CBL ASSY,MARQUETTE/RCTN,ROHS
• 00690103196467: CBL ASSY,MARQUETTE/RCTN,ROHS
• 00690103196450: CBL ASSY,MARQUETTE/RCTN,ROHS
• 00690103196443: CBL ASSY,MARQUETTE/RCTN,ROHS
• 00690103196436: CABLE ASSY, TRUWAVE
• 00690103196429: CABLE ASSY, TRUWAVE
• 00690103196412: CABLE ASSY,EW TRUWAVE
• 00690103196405: CABLE ASSY,EW SIEMENS, ROHS
• 00690103196399: CABLE ASSY, EW SIEMENS, ROHS
• 00690103196382: CABLE ASSY,EW SIMPLE