FDA.reportPublic FDA data

HemoSphere Alta

Primary DI
00690103217964
Brand
HemoSphere Alta
Company
Edwards Lifesciences LLC
Model
ALTASR1
Catalog number
ALTASR1
Device description
HemoSphere Alta advanced monitor (Smart Recovery)
Published
2025-03-13
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
DSBPlethysmograph, Impedance
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLThermometer, Electronic, Clinical
MUDOximeter, Tissue Saturation
QAQAdjunctive Predictive Cardiovascular Indicator
QEMCerebral Oximeter
QMSAdjunctive Open Loop Fluid Therapy Recommender
QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQECatheter, Oximeter, Fiber-OpticCardiovascular2
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DSBPlethysmograph, ImpedanceCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MUDOximeter, Tissue SaturationCardiovascular2
QAQAdjunctive Predictive Cardiovascular IndicatorCardiovascular2
QEMCerebral OximeterCardiovascular2
QMSAdjunctive Open Loop Fluid Therapy RecommenderCardiovascular2
QNLMedium-Term Adjunctive Predictive Cardiovascular IndicatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232294000
K242451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232294000HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One)Edwards Lifesciences, LLC2023-10-31DQK
K242451000HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)Edwards Lifesciences2024-12-09DYG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103217964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103217964006901032179646901032179640690103217964

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose multi-parameter bedside monitorAn electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690103222388PASCAL Precision20000GS20000GSLA2026-09-24
00690103216943PASCAL20000IS20000ISA2022-09-19
00690103216967PASCAL PRECISION20000GSA20000GSA2022-09-19
00690103221664PASCAL Ace with Capture Clarity Valve Repair System30000ACEMR30000ACEMRA2026-09-24
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

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Primary DI, Brand, Company table
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00195278840202MACGe Medical Systems Information Technologies, Inc.DQK2026-10-13
06953825911881N/AShenzhen Urion Technology Co., LtdDXN2026-10-13
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00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
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06933257947030YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
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