FDA.reportPublic FDA data

Neteera 130H-Plus

Primary DI
07290117120057
Brand
Neteera 130H-Plus
Company
NETEERA TECHNOLOGIES LTD
Model
210-00-101-00
Published
2026-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231733000Neteera 130H-Plus Vital Sign Monitoring SensorNeteera Technologies , Ltd.2024-02-09DRT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290117120061PackageGS150In Commercial Distribution
27290117120075PackageGS1300In Commercial Distribution
07290117120057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011712006117290117120061
2729011712007527290117120075
07290117120057072901171200577290117120057

GMDN Terms#

Term, Definition table
TermDefinition
Contactless patient status monitorAn electronic device designed for professional use in a clinical or homecare setting for contactless intermittent assessment or continuous monitoring of pulse and respiration rates, and bed exit/occupancy, of a patient during rest or mild body movement. It consists of a small unit, similar to a motion sensor, which uses radar-based micro-motion detection from a close distance (<=5ft) [i.e., non-patient-contact] and has integrated interpretive software algorithms to measure and communicate data to a web-based cloud platform for display at a remote centralized patient monitor.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit176 Degrees Fahrenheit

Regulatory Flags#

DUNS number
600710452
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290117120002Neteera 130H/131H Vital Sign Monitoring Sensor130-00-101-002026-05-05
07290117120026Neteera 130H US Kit (DRZ)130-00-102-002021-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.BZQ2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.BZQ2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.BZQ2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.BZQ2026-06-03
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZQ2026-06-02
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRT2026-05-27
20653405024962CONMEDConmed CorporationBZQ2026-03-24
10889483224366MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
10889483225295MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.BZQ2025-12-10