FDA.reportPublic FDA data

PRESSURE MONITORING ACCESSORY

Primary DI
07460691949867
Brand
PRESSURE MONITORING ACCESSORY
Company
Edwards Lifesciences LLC
Model
DTSS
Catalog number
DTSS
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
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
07460691949867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07460691949867074606919498677460691949867

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
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
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
00690103019704HEART VALVE ACCESSORY1174M1174M242026-04-06
00690103019711HEART VALVE ACCESSORY1174M1174M262026-04-06
00690103019728HEART VALVE ACCESSORY1174M1174M282026-04-06
00690103019735HEART VALVE ACCESSORY1174M1174M302026-04-06
00690103019742HEART VALVE ACCESSORY1174M1174M322026-04-06
00690103019759HEART VALVE ACCESSORY1174M1174M342026-04-06
00690103019766HEART VALVE ACCESSORY1174M1174M362026-04-06
00690103019773HEART VALVE ACCESSORY1174M1174M382026-04-06
00690103019780HEART VALVE ACCESSORY1174M1174M402026-04-06
00690103019797HEART VALVE ACCESSORY1175T1175T262026-04-06
00690103019803HEART VALVE ACCESSORY1175T1175T282026-04-06

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Primary DI, Brand, Company table
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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
00761887005464PryorPRYOR PRODUCTSFOX2026-05-26
00810050863469AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00810050863476AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00761887005419PryorPRYOR PRODUCTSFOX2026-05-25
00761887005433PryorPRYOR PRODUCTSFOX2026-05-25
00761887005440Connected RockPRYOR PRODUCTSFOX2026-05-25
00761887005457CorCytePRYOR PRODUCTSFOX2026-05-25
00761887005426PryorPRYOR PRODUCTSFOX2026-05-21
00810050863445Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863452Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863414Pole MountLIFEPORT, LLCFOX2026-04-28
00810050863421Pole MountLIFEPORT, LLCFOX2026-04-28
B458205997000HVP CartThe Wells Johnson CompanyFOX2026-04-20
B458205998000Wells Johnson Hymen CartThe Wells Johnson CompanyFOX2026-04-20
00810050863407Load RampLIFEPORT, LLCFOX2026-04-17
09420012405890Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
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09420012416728Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
00810050863391Medical CabinetLIFEPORT, LLCFOX2026-04-07
04260217220158chapot® table System Siemens Artis zee / Q / Q.zenAmtrion GmbHFOX2026-03-30
04260217220196chapot® table System Siemens ARTIS pheno / iconoAmtrion GmbHFOX2026-03-30
09420012405999Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-26
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