FDA.reportPublic FDA data

TruWave

Primary DI
00690103204407
Brand
TruWave
Company
Edwards Lifesciences LLC
Model
PXVJZ30004
Catalog number
PXVJZ30004
Device description
Pressure Monitoring Set
Published
2019-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXOTransducer, Pressure, Catheter Tip
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXOTransducer, Pressure, Catheter TipCardiovascular2
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141495000
K142749000
K161962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141495000TRUWAVE DISPOSABLE PRESSURE TRANSDUCEREdwards Lifesciences, LLC2014-09-03DXO
K142749000TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC2015-01-18DXO
K161962000VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC2016-11-28KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50690103204402PackageGS110In Commercial Distribution
00690103204407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010320440250690103204402
00690103204407006901032044076901032044070690103204407

GMDN Terms#

Term, Definition table
TermDefinition
Invasive-pressure external transducer, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place.

Contacts#

Phone, Email table
PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags#

DUNS number
134139174
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103219500Edwards Reusable Rail10500RL10500RL2025-07-09
00690103205084FOGARTY120403FP120403FP2020-09-15
00690103218602SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
00690103218626SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
00690103218633SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103000245SWAN-GANZ TRUE SIZE096F6096F6P2016-09-03
00690103000269SWAN-GANZ110F5110F52016-09-03
00690103000276SWAN-GANZ TRUE SIZE111F7111F7P2016-09-03
00690103000313SWAN-GANZ TRUE SIZE114F7114F7P2016-09-03
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403524038TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403524502TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403524649TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403525028TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403525424TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-05
00885403525585TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403525684TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403525943TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403526322TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403526599TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403529897TRUWAVE,VAMPBecton, Dickinson And CompanyDXO2026-09-05
00885403539889TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403539919TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403541837TruwaveBecton, Dickinson And CompanyDXO2026-09-05
00885403541868TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542056TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542186TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542193TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542209TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542223TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542247TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542483TRUWAVE,VAMP JR.Becton, Dickinson And CompanyDXO2026-09-05
00885403542520TRUWAVE,VAMP JR.Becton, Dickinson And CompanyDXO2026-09-05
00885403542643TRUWAVE, VAMPBecton, Dickinson And CompanyDXO2026-09-05
00885403542667TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00885403542704TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-05
00885403542742TRUWAVE, VAMP JRBecton, Dickinson And CompanyDXO2026-09-05
00885403542803TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542810TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-05