TruWave Cables 896507027

GUDID 00690103218305

CBL ASSY,MARQUETTE/RCTN,ROHS

Edwards Lifesciences LLC

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• Primary Device ID: 00690103218305
• NIH Device Record Key: be6d1165-19c2-4f94-be00-bf38d4f3d1be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruWave Cables
• Version Model Number: 896507027
• Catalog Number: 896507027
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch
• Length: 162 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103218305 [Primary]

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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-17
• Device Publish Date: 2023-11-09

On-Brand Devices [TruWave Cables]

• 00690103210552: CABLE ASSY, EW SIEMENS, MDR
• 00690103210484: CABLE ASSY, 6 PIN/MS3106, MDR
• 00690103210590: CABLE ASSY,EW,BI,GE,ROHS,MDR
• 00690103210583: CABLE ASSY, TRUWAVE, ROHS, MDR
• 00690103210576: CBL ASY,EW 12PN/FKDA DNSHI,MDR
• 00690103210538: CBL ASSY,4 PIN/AMPHENOL,MDR
• 00690103210521: CBL ASSY,12 PIN/KONTRON,MDR
• 00690103210514: CABLE ASSY,EW TRUWAVE,ROHS,MDR
• 00690103210507: CBLASY,5 PIN/NIHON KHODEN,MDR
• 00690103210491: CABLE ASSY, TRUWAVE, ROHS, MDR
• 00690103210477: CABLE ASSY,10PIN/SIEMENS,MDR
• 00690103210460: CABLE ASSY,10PIN/SIEMENS,MDR
• 00690103218305: CBL ASSY,MARQUETTE/RCTN,ROHS
• 00690103210613: CABLE ASSY, TRUWAVE, MDR
• 00690103210606: CABLE ASSY, TRUWAVE, MDR
• 00690103210545: CABLE ASSEMBLY, EW, ROHS, MDR