FDA.reportPublic FDA data

TRUWAVE

Primary DI
00885403541868
Brand
TRUWAVE
Company
Becton, Dickinson And Company
Model
581WV06
Catalog number
581WV06
Device description
PRESSURE MONITORING ACCESSORY
Published
2026-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
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
50885403541863PackageGS120In Commercial Distribution
00690103002249PreviousGS10
00885403541868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088540354186350885403541863
00690103002249006901030022496901030022490690103002249
00885403541868008854035418688854035418680885403541868

GMDN Terms#

Term, Definition table
TermDefinition
Invasive blood pressure monitoring tubing setA collection of devices that includes the necessary tubing and other items, e.g., connectors, stopcock(s), clamps and filters, used as an external connection for invasive blood pressure measurement. This set will interface, either directly or from an intermediate stopcock, between the applied invasive catheter and the measuring transducer. It will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.

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
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
00885403542643TRUWAVE, VAMPBecton, 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