FDA.reportPublic FDA data

Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®

Primary DI
07290016169232
Brand
Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®
Company
EARLYSENSE LTD
Model
AME-00202 HR US
Catalog number
Hill-Rom PN 200898
Published
2018-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180079000Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor ActivationHill-Rom, Inc.2018-05-07BZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016169239PackageGS110In Commercial Distribution
07290016169232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001616923917290016169239
07290016169232072900161692327290016169232

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, multifunctionA small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module.

Regulatory Flags#

DUNS number
649822657
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016169102EarlySense® InSight™N/AAME-01340-02 US2017-06-16
07290016169393EarlySense® InSight™Insight at HomeAME-020212021-07-07
07290016169089EarlySense® Bedside UnitN/AAME-00900 US2017-06-16
07290016169140EarlySense® Central Display UnitN/AAME-002500 US2017-06-16
17290016169109EarlySense® InSight™N/AAME-01340-02 US2017-06-16
07290016169249EarlySense® BEX SensorAME-01610 US2018-07-29
17290016169239Hill-Rom® Heart and Respiration Rate Monitoring SyAME-00202 HR USHill-Rom PN 2008982018-07-29
17290016169246EarlySense® BEX SensorAME-01610 US2018-07-29
07290016169010EarlySense® Contact-Free SensorN/AAME-00200 US2017-06-15
17290016169017EarlySense® Contact-Free SensorN/AAME-00200 US2017-06-15
07290016169065EarlySense® Chair SensorN/AAME-00271 US2017-06-15

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