FDA.reportPublic FDA data

TRUWAVE

Primary DI
00690103206050
Brand
TRUWAVE
Company
Edwards Lifesciences LLC
Model
PXVPL20001
Catalog number
PXVPL20001
Device description
Pressure Monitoring Set
Published
2019-07-09
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
50690103206055PackageGS110In Commercial Distribution
00690103206050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010320605550690103206055
00690103206050006901032060506901032060500690103206050

GMDN Terms#

Term, Definition table
TermDefinition
Arterial blood sampling kitA collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. 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
00690103221664PASCAL Ace with Capture Clarity Valve Repair System30000ACEMR30000ACEMRA2026-09-24
00690103222388PASCAL Precision20000GS20000GSLA2026-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00885403533665TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543282TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543299TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543305TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543312TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543428TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543435TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543459TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543466TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543473TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543480TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544128TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544135TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544142TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544159TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544166TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544180TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544432TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544470TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544487TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544494TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544500TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544524TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544531TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544555TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544562TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18