FDA.reportPublic FDA data

Heart and Respiration Rate Monitoring System powered by EarlySense

Primary DI
00887761975705
Brand
Heart and Respiration Rate Monitoring System powered by EarlySense
Company
HILL-ROM, INC.
Model
P211560
Device description
EarlySense Sensor Assembly
Published
2021-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00887761975705PackageGS11In Commercial Distribution
00887761975712PackageGS110In Commercial Distribution
00887761981720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887761975705008877619757058877619757050887761975705
00887761975712008877619757128877619757120887761975712
00887761981720008877619817208877619817200887761981720

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)445-3730us.customerservice@hill-rom.com

Regulatory Flags#

DUNS number
004245668
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615521014476ALLEN102001F-LH5002023-05-30
00615521015299ALLEN900111F-TWE2BER2023-05-31
00615521014650ALLEN102001F-LHPBMAQNP2023-05-30
00615521014803ALLEN102007F-NTSHDE2023-05-30
00615521014810ALLEN102007F-NTSHDUK2023-05-30
00615521031473ALLEN102001I-LHMM2023-05-30
00615521013790ALLEN107002F-ABSLT2BER2023-05-26
00615521014391ALLEN102005F-FBD850BER2023-05-26
00615521014735ALLEN102005F-MDTPTB32023-05-26
00615521014889ALLEN102004F-PSTBHD2023-05-26
00615521015015ALLEN103002F-SFPASBER2023-05-26
00615521015046ALLEN102005F-SLD850BER2023-05-26
00615521014599ALLEN102001F-LHMAQ2023-05-30
00615521031459ALLEN102001F-10056MAQ2023-05-30
00615521031466ALLEN102001F-10057MAQ2023-05-30
00615521012649ALLEN106002F-100152023-05-26
00615521013783ALLEN107002F-ABSLT2023-05-26
00615521014506ALLEN102001F-LH720MAQ2023-05-26
00615521002848ALLEN1030062026-04-24
00615521031008ALLEN1010052026-04-24

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00850064210224Sibel Spacelabs Trek ChargerSibel Health Inc.BZQ2025-04-02
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00850068747092Happy HealthHAPPY HEALTH, INC.BZQ2025-04-02
00850064210002ANNE Chest Sensor KitSibel Health Inc.BZQ2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.BZQ2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.BZQ2025-03-26
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.BZQ2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.BZQ2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.BZQ2025-03-26
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.BZQ2025-03-13
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDBZQ2025-03-05
G2331000000SansaTMHuxley Medical, Inc.BZQ2024-10-21
G2331000010SansaTMHuxley Medical, Inc.BZQ2024-10-21
G2331000020SansaTMHuxley Medical, Inc.BZQ2024-10-21
10843997006184Radius VSMMASIMO CORPORATIONBZQ2024-08-19
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZQ2024-06-19
00195278656681Portrait CVAXBGE Medical Systems Information Technologies, Inc.BZQ2024-04-30
00195278659446Portrait CSSXBGE Medical Systems Information Technologies, Inc.BZQ2024-04-30
00195278697165PORTRAIT HSWXBGE Healthcare Finland OyBZQ2024-04-30
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