FDA.reportPublic FDA data

TruWave, VAMP Plus

Primary DI
00885403524779
Brand
TruWave, VAMP Plus
Company
Becton, Dickinson And Company
Model
PXVP2272
Catalog number
PXVP2272
Device description
Pressure monitoring set
Published
2026-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

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
K183413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183413000TruWave Disposable Pressure TransducerEdwards Lifeciences, LLC2019-05-01DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403524774PackageGS110In Commercial Distribution
07460691950184PreviousGS10
00885403524779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088540352477450885403524774
07460691950184074606919501847460691950184
00885403524779008854035247798854035247790885403524779

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
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Store in a cool, dry place

Regulatory Flags#

DUNS number
145014099
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30382902263068BD BBL™ Prompt™ Inoculation System2263062263062016-04-29
30382904203147BD SurePrep™ Capillary Tubes- PLAIN4203144203142018-05-25
30382904203154BD SurePrep™ Capillary Tubes- PLAIN4203154203152018-05-25
30382904203161BD SurePrep™ Capillary Tubes- HEPARINIZED4203164203162018-05-25
30382904203178BD SurePrep™ Capillary Tubes- HEPARINIZED4203174203172018-05-25
30382904203185BD SurePrep™ Capillary Tubes- PRECALIBRATED4203184203182018-05-25
00885403530534Fogarty12TLW404F12TLW404F2026-08-14
00885403530541Fogarty12TLW803F12TLW803F2026-08-14
00885403530558Fogarty12TLW804F12TLW804F2026-08-14
00885403530572Fogarty12TLW806F12TLW806F2026-08-14
00885403530589FOGARTY12TLW807F12TLW807F2026-08-14
00382904411244BD ProbeTec™ (GC) Qx Amplified DNA Assay4411244411242016-07-07
00382902780519BD Macro-Vue™ Card Test Rotator2780512780512016-05-19
00885403522324Swan-Ganz151F7151F72026-07-31
00885403523581VAMP48VMP10648VMP1062026-07-31
00885403523598VAMP48VMP12048VMP1202026-07-31
00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31

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
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
07460691949003TRUWAVE (3 CC) /VAMP 88 IN (225 CM)Edwards Lifesciences LLCDXO2024-09-05