TRUWAVE CABLES 896034024

GUDID 00690103210514

CABLE ASSY,EW TRUWAVE,ROHS,MDR

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use Invasive-pressure external transducer, single-use Invasive-pressure external transducer, single-use Invasive-pressure external transducer, single-use Invasive-pressure external transducer, single-use Invasive-pressure external transducer, single-use Invasive-pressure external transducer, single-use Invasive-pressure external transducer, single-use Invasive-pressure external transducer, single-use Invasive-pressure external transducer, single-use Invasive-pressure external transducer, single-use Invasive-pressure external transducer, single-use
Primary Device ID00690103210514
NIH Device Record Key7c871e20-3530-4001-b267-072182f93dda
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUWAVE CABLES
Version Model NumberPX1800
Catalog Number896034024
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com

Device Dimensions

Length162 Inch
Length162 Inch
Length162 Inch
Length162 Inch
Length162 Inch
Length162 Inch
Length162 Inch
Length162 Inch
Length162 Inch
Length162 Inch
Length162 Inch
Length162 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103210514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXOTransducer, Pressure, Catheter Tip

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-03
Device Publish Date2020-07-24

On-Brand Devices [TRUWAVE CABLES]

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

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