FDA.reportPublic FDA data

PX1800 – Truwave Cables

Primary DI
00690103218541
Brand
PX1800 – Truwave Cables
Company
Edwards Lifesciences LLC
Model
896019030
Catalog number
896019030
Device description
CABLE ASSY, 6 PIN/MS3106, MDR
Published
2024-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXOTransducer, Pressure, Catheter Tip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXOTransducer, Pressure, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142749000TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC2015-01-18DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103218541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103218541006901032185416901032185410690103218541

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
134139174
Device count
1
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
00885403523581VAMPBecton, Dickinson And CompanyDXO2026-07-31
00885403523598VAMPBecton, Dickinson And CompanyDXO2026-07-31
00885403523734VAMPBecton, Dickinson And CompanyDXO2026-07-31
00885403524281TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-07-31
00885403524694TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-07-31
00885403524922TruWaveBecton, Dickinson And CompanyDXO2026-07-31
00885403525066TruWave, VAMPBecton, Dickinson And CompanyDXO2026-07-31
00885403525547TruWave, VAMPBecton, Dickinson And CompanyDXO2026-07-31
00885403525608TruWave, VAMPBecton, Dickinson And CompanyDXO2026-07-31
00885403525646TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-07-31
00885403542049TruWaveBecton, Dickinson And CompanyDXO2026-07-31
00885403542728TruWave, VAMP Jr.Becton, Dickinson And CompanyDXO2026-07-31
00885403542766TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-07-31
00885403542926TruWave, VAMPBecton, Dickinson And CompanyDXO2026-07-31
00885403524618TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524717TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524779TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524809TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524847TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524946TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403525462TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403525486TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403527411TruWaveBecton, Dickinson And CompanyDXO2026-05-30
07460691952775TRUWAVEEdwards Lifesciences LLCDXO2026-03-20
00690103210828Combo KitsEdwards Lifesciences LLCDXO2025-07-15
07460691925298TRUWAVE/VAMPEdwards Lifesciences LLCDXO2024-09-05
07460691925731TRUWAVE X 2 (3 CC) /VAMP 98 IN (250 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691926769TRUWAVE, VAMPEdwards Lifesciences LLCDXO2024-09-05
07460691930179TRUWAVE X 2 (3CC) / VAMP JR 54 IN (136 CM)Edwards Lifesciences LLCDXO2024-09-05
07460691948990TRUWAVE X 2 (3 CC) /VAMP 86 IN (220 CM)Edwards Lifesciences LLCDXO2024-09-05