FDA.reportPublic FDA data

HEMOSPHERE

Primary DI
00690103199338
Brand
HEMOSPHERE
Company
Edwards Lifesciences LLC
Model
HEMDPT1000
Catalog number
HEMDPT1000
Device description
DPT OUT CABLE
Published
2019-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQECatheter, Oximeter, Fiber-Optic
DQKComputer, Diagnostic, Programmable
QAQAdjunctive Predictive Cardiovascular Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQECatheter, Oximeter, Fiber-OpticCardiovascular2
DQKComputer, Diagnostic, ProgrammableCardiovascular2
QAQAdjunctive Predictive Cardiovascular IndicatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180881000HemoSphere Advanced Monitor, HemoSphere Pressure CableEdwards Lifesciences, LLC2018-11-16DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103199338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103199338006901031993386901031993380690103199338

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15.2Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in 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

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
Primary DIBrandCompanyProduct codePublished
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00195278507037Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-03-26
00690103000382SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQE2026-03-16
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17540279105018EARTIcentia Inc.DQK2024-03-26
17540279200072CardioSTATIcentia Inc.DQK2024-03-26
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00191506033002AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
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