FDA.reportPublic FDA data

WAVE Clinical Platform

Primary DI
00887761943148
Brand
WAVE Clinical Platform
Company
HILL-ROM, INC.
Model
DB
Device description
WAVE Clinical Platform
Published
2026-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWIMonitor, physiological, patient (without arrhythmia detection or alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250135000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250135000WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical2026-01-16MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887761943148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761943148008877619431488877619431480887761943148

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment clinical data interfacing softwareAn application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.

Contacts#

Phone, Email table
PhoneEmail
+1(866)573-8807us.customerservice@hill-rom.com

Regulatory Flags#

DUNS number
004245668
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615521002848ALLEN1030062026-04-24
00615521031008ALLEN1010052026-04-24
00615521031015ALLEN1010052026-04-24
00615521031022ALLEN1020082026-04-24
00615521070007ALLEN1030062026-04-24
00848340016806ALLENA-212002026-04-24
00887761981720Heart and Respiration Rate Monitoring System powered by EarlySenseP2115602021-09-23
00887761985155Heart and Respiration Rate Monitoring System powered by EarlySenseP2008982018-08-22
00887761976870pro+P7924ARENT022026-04-21
00887761007536pro+P3255A072026-04-20
00887761007543pro+P3255A082026-04-20
00887761976863pro+P7924ARENT012026-04-20
00887761976887pro+P3255ARENT012026-04-20
00887761007666pro+P7924A142026-03-27
00887761007697pro+P7924ARENT032026-03-27
00887761007703pro+P7924ARENT042026-03-27
00887761007505pro+P006800A062026-03-25
00887761007512pro+P006800A072026-03-25
00887761007550pro+P3255A092026-03-25
00887761007567pro+P3255A102026-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719689142124QMAPP Fysicon B.V.MWI2026-05-19
08719689142131QMAPP Fysicon B.V.MWI2026-05-19
08719689142162QMAPP Fysicon B.V.MWI2026-05-19
08719689142179QMAPP Fysicon B.V.MWI2026-05-19
10197344213245MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08
10197344213252MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08
10197344213238MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-04-23
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.MWI2026-03-18
B153301010AirStrip ONE Client iOSAirstrip Technologies, Inc.MWI2026-03-18
B153301020AirStrip ONE Client AndroidAirstrip Technologies, Inc.MWI2026-03-18
10884838113777MR Patient Care Adult SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
10884838115092MR Patient Care Pediatric SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2026-03-16
17540262100143Change Healthcare Cardiology HemoChange Healthcare Canada CompanyMWI2026-03-09
17540262170047Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyMWI2026-03-09
10884838129938MR Patient Care Temperature Sensor JacketPhilips Medizin Systeme Böblingen GmbHMWI2026-01-06
14250892908509JaegerJaeger Medical GmbHMWI2025-11-24
14250892908936JaegerJaeger Medical GmbHMWI2025-11-24
34250892909012JaegerJaeger Medical GmbHMWI2025-11-24
34250892909029JaegerJaeger Medical GmbHMWI2025-11-24
34250892908367JaegerJaeger Medical GmbHMWI2025-10-31
34250892908541JaegerJaeger Medical GmbHMWI2025-10-31
34250892908589JaegerJaeger Medical GmbHMWI2025-10-31
10884838111407MR Patient Care Temperature Sensor JacketPhilips Medizin Systeme Böblingen GmbHMWI2025-05-30
10884838117874MR Patient Care Pediatric SpO2 ClipPhilips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120805MR Patient Care Infant NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120812MR Patient Care Pediatric NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120829MR Patient Care Small Adult NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120836MR Patient Care Adult NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120843MR Patient Care Adult-Long NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22
10884838120867MR Patient Care Large Adult NBP Cuffs (10)Philips Medizin Systeme Böblingen GmbHMWI2025-05-22