FDA.reportPublic FDA data

EarlySense® InSight™

Primary DI
07290016169102
Brand
EarlySense® InSight™
Company
EARLYSENSE LTD
Model
N/A
Catalog number
AME-01340-02 US
Published
2017-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K152911000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152911000EarlySense Insight SytemEarlysense, Ltd.2016-05-06BZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016169109PackageGS15In Commercial Distribution
07290016169102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001616910917290016169109
07290016169102072900161691027290016169102

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.

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
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
07290016169232Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®AME-00202 HR USHill-Rom PN 2008982018-07-29
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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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
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