FDA.reportPublic FDA data

TRUWAVE, VAMP PLUS

Primary DI
07460691955936
Brand
TRUWAVE, VAMP PLUS
Company
Edwards Lifesciences LLC
Model
PXVP2284DZ
Catalog number
PXVP2284DZ
Device description
PRESSURE MONITORING SET
Published
2016-09-03
Public version status
Update
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
K142749000
K181684000
K896819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142749000TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC2015-01-18DXO
K181684000VAMP Plus Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC2018-11-08KRA
K896819000VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTIONBaxter Healthcare Corp1990-01-19KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57460691955931PackageGS110In Commercial Distribution
07460691955936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5746069195593157460691955931
07460691955936074606919559367460691955936

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.

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
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
00690103020212CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M242015-09-24
00690103020229CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M262015-09-24
00690103020236CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M282015-09-24
00690103020243CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M302015-09-24
00690103020250CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M322015-09-24
00690103020267CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M342015-09-24
00690103020274CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M362015-09-24
00690103020281CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M382015-09-24
00690103020298CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL44504450M402015-09-24
00690103219807SAPIEN Stabilizer Rail System9880SRS9880SRSA2026-10-22
00690103222135PASCAL Precision20000ISM20000ISMTA2026-10-22
00690103222388PASCAL Precision20000GS20000GSLA2026-09-24
00690103216943PASCAL20000IS20000ISA2022-09-19
00690103216967PASCAL PRECISION20000GSA20000GSA2022-09-19
00690103221664PASCAL Ace with Capture Clarity Valve Repair System30000ACEMR30000ACEMRA2026-09-24
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

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