FDA.reportPublic FDA data

Combo Kit

Primary DI
00690103200324
Brand
Combo Kit
Company
Edwards Lifesciences LLC
Model
PXVMPL260
Catalog number
PXVMPL260
Device description
Pressure Monitoring Set
Published
2019-04-17
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
50690103200329PackageGS110In Commercial Distribution
00690103200324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069010320032950690103200329
00690103200324006901032003246901032003240690103200324

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
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00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06
00690103019735HEART VALVE ACCESSORY1174M1174M302026-04-06
00690103019742HEART VALVE ACCESSORY1174M1174M322026-04-06
00690103019759HEART VALVE ACCESSORY1174M1174M342026-04-06
00690103019766HEART VALVE ACCESSORY1174M1174M362026-04-06
00690103019773HEART VALVE ACCESSORY1174M1174M382026-04-06
00690103019780HEART VALVE ACCESSORY1174M1174M402026-04-06
00690103019797HEART VALVE ACCESSORY1175T1175T262026-04-06
00690103019803HEART VALVE ACCESSORY1175T1175T282026-04-06
00690103019810HEART VALVE ACCESSORY1175T1175T302026-04-06
00690103019827HEART VALVE ACCESSORY1175T1175T322026-04-06
00690103019834HEART VALVE ACCESSORY1175T1175T342026-04-06
00690103019841HEART VALVE ACCESSORY1175T1175T362026-04-06
00690103019858HEART VALVE ACCESSORY1175T1175T382026-04-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
07640132622690M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622157M-CATH MicrocatheterAcrostak (Schweiz) AGKRA2018-05-15
10351688507990MedexICU MEDICAL, INC.KRA2016-12-30
10351688508669MedexICU MEDICAL, INC.KRA2016-12-30
10351688505620MedexICU MEDICAL, INC.KRA2016-12-29
10351688508768MedexICU MEDICAL, INC.KRA2016-10-19
10351688508775MedexICU MEDICAL, INC.KRA2016-10-19
10351688508782MedexICU MEDICAL, INC.KRA2016-10-19
10351688508805MedexICU MEDICAL, INC.KRA2016-10-19
10080196172405MedlineMEDLINE INDUSTRIES, INC.DXO2016-10-14
10351688506856MedexICU MEDICAL, INC.KRA2016-10-12
10351688506863MedexICU MEDICAL, INC.KRA2016-10-12
10351688508898MedexICU MEDICAL, INC.KRA2016-10-11
10351688509932MedexICU MEDICAL, INC.KRA2016-10-11
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