FDA.reportPublic FDA data

TruWave

Primary DI
57460691956143
Brand
TruWave
Company
Edwards Lifesciences LLC
Model
MP111
Catalog number
MP111
Device description
PRESSURE MONITORING ACCESSORY
Published
2025-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOXStand, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925638000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925638000PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600Baxter Healthcare Corp1993-10-18DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57460691956143PackageGS120In Commercial Distribution
07460691956148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5746069195614357460691956143
07460691956148074606919561487460691956148

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure transducer holderA device used to secure a pressure transducer used for invasive blood pressure measurement at a desired height. The holder can be fastened to (e.g., a bed or an operating table) and can be adjusted so that the transducer is at the same level as the heart of the patient. This is a reusable device.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
00690103221664PASCAL Ace with Capture Clarity Valve Repair System30000ACEMR30000ACEMRA2026-09-24
00690103222388PASCAL Precision20000GS20000GSLA2026-09-24
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
00690103000245SWAN-GANZ TRUE SIZE096F6096F6P2016-09-03
00690103000269SWAN-GANZ110F5110F52016-09-03
00690103000276SWAN-GANZ TRUE SIZE111F7111F7P2016-09-03
00690103000313SWAN-GANZ TRUE SIZE114F7114F7P2016-09-03
00690103220223TRIFORMIS RESILIA Tricuspid Valve11300T2511300T252026-05-28
00690103220230TRIFORMIS RESILIA Tricuspid Valve11300T2711300T272026-05-28
00690103220247TRIFORMIS RESILIA Tricuspid Valve11300T2911300T292026-05-28
00690103220254TRIFORMIS RESILIA Tricuspid Valve11300T3111300T312026-05-28
00690103220261TRIFORMIS RESILIA Tricuspid Valve11300T3311300T332026-05-28
00690103019643HEART VALVE ACCESSORY1170117019MM2026-04-06
00690103019650HEART VALVE ACCESSORY1170117021MM2026-04-06
00690103019674HEART VALVE ACCESSORY1170117025MM2026-04-06
00690103019698HEART VALVE ACCESSORY1170117029MM2026-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050863629Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-09-22
00628678604124Micro Base ProTechnimount Medicale IncFOX2026-09-21
00628678604131PS5000 Clamp Block FQTechnimount Medicale IncFOX2026-09-21
00628678604148Bracket Pro Serie® 350 – MDTechnimount Medicale IncFOX2026-09-21
00628678604155Bracket Pro Serie® 360 - FQTechnimount Medicale IncFOX2026-09-21
00628678604162Bracket Pro Serie® 71Technimount Medicale IncFOX2026-09-21
00628678604179O2 Mount PS5000Technimount Medicale IncFOX2026-09-21
00628678604186Bracket Pro Serie® 26 – FQTechnimount Medicale IncFOX2026-09-21
00628678604193CARDIATEK®Technimount Medicale IncFOX2026-09-21
00810050863612Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-09-21
00628678604087ContinuuMed™ RIVTechnimount Medicale IncFOX2026-09-18
00628678604094ContinuuMed™ PVTTechnimount Medicale IncFOX2026-09-18
00628678604100Standard Surface BaseTechnimount Medicale IncFOX2026-09-18
00628678604117Universal BaseTechnimount Medicale IncFOX2026-09-18
00810050863544Arch InstallationLIFEPORT, LLCFOX2026-08-25
00810050863551IV PoleLIFEPORT, LLCFOX2026-08-25
00810050863568Arch InstallationLIFEPORT, LLCFOX2026-08-25
00810050863575Arch AssemblyLIFEPORT, LLCFOX2026-08-25
00810050863506Medical CabinetLIFEPORT, LLCFOX2026-08-03
00841027105695Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2026-06-26
00810050863483AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-06-08
00840117346307Vital Signs Stand, Compatible with item 10843Dynarex CorporationFOX2026-06-08
00761887005471PryorPRYOR PRODUCTSFOX2026-05-31
04061162002116CIM med GmbHCIM med GmbHFOX2026-05-31
04061162051893CIM med GmbHCIM med GmbHFOX2026-05-31
00885403530145TRUCLIPBecton, Dickinson And CompanyFOX2026-05-30
00840432200056Verathon®Verathon Medical (Canada) ULCFOX2026-05-28
00761887005426PryorPRYOR PRODUCTSFOX2026-05-21
00810050863445Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863452Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15