FDA.reportPublic FDA data

TRUWAVE, VAMP

Primary DI
00885403542643
Brand
TRUWAVE, VAMP
Company
Becton, Dickinson And Company
Model
PXVK268
Catalog number
PXVK268
Device description
PRESSURE MONITORING KIT
Published
2026-09-05
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
50885403542648PackageGS120In Commercial Distribution
07460691955028PreviousGS10
00885403542643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088540354264850885403542648
07460691955028074606919550287460691955028
00885403542643008854035426438854035426430885403542643

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, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Special Storage Conditions (see IFU)
Special Storage Condition, Specify00Store in a cool, dry place
Special Storage Condition, Specify00This way up

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
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403521624SWAN-GANZD97130F5D97130F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403524038TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403524502TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403524649TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403525028TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403525424TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-05
00885403525585TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403525684TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403525943TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403526322TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403526599TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403529897TRUWAVE,VAMPBecton, Dickinson And CompanyDXO2026-09-05
00885403539889TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403539919TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403541837TruwaveBecton, Dickinson And CompanyDXO2026-09-05
00885403541868TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542056TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542186TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542193TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542209TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542223TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542247TruWaveBecton, Dickinson And CompanyDXO2026-09-05
00885403542483TRUWAVE,VAMP JR.Becton, Dickinson And CompanyDXO2026-09-05
00885403542520TRUWAVE,VAMP JR.Becton, Dickinson And CompanyDXO2026-09-05
00885403542667TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542704TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-05
00885403542742TRUWAVE, VAMP JRBecton, Dickinson And CompanyDXO2026-09-05
00885403542803TRUWAVEBecton, Dickinson And CompanyDXO2026-09-05
00885403542810TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-05
00885403524861TRUWAVE, VAMP PLUSBecton, Dickinson And CompanyDXO2026-09-04
00885403524960TRUWAVEBecton, Dickinson And CompanyDXO2026-09-04