FDA.reportPublic FDA data

HeraBEAT

Primary DI
07290111520129
Brand
HeraBEAT
Company
HERA MED LTD
Model
HeraBEAT US
Catalog number
PACHBT000US
Device description
HeraBEAT US is a hand-held, battery powered audio Doppler device integrated with 2MHz probe, used for detecting and displaying the fetal heart rate (FHR) and FHR sound.The device uses an optical sensor to distinguish between the FHR and the maternal heart rate (MHR) to eliminate “crosstalk” in the FHR display.
Published
2020-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
KNGMonitor, Ultrasonic, Fetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNGMonitor, Ultrasonic, FetalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191110000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191110000HeraBEAT™ USHeramed, Ltd.2019-11-14KNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290111520126PackageGS112In Commercial Distribution
07290111520129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011152012617290111520126
07290111520129072901115201297290111520129

GMDN Terms#

Term, Definition table
TermDefinition
Foetal Doppler systemA portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Regulatory Flags#

DUNS number
600058601
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290111520126HeraBEATHeraBEAT USPACHBT000US2020-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850067960003Imex 5MHZ DOPPLER PROBE, PD2IMEX, LLCKNG2026-05-18
00850067960027Imex 8MHZ DOPPLER PROBE, PD2IMEX, LLCKNG2026-05-18
00850067960034Imex 3MHZ DOPPLER PROBE,PD2IMEX, LLCKNG2026-05-18
00850067960058Imex DOPPLER PROBE, 2MHZ, H2O PROOF PDIIIMEX, LLCKNG2026-05-18
00850067960041Imex 2MHZ Doppler Probe PD2IMEX, LLCKNG2026-05-13
00860011754510Imex Pocket Dop II Doppler SystemIMEX, LLCKNG2026-05-13
05051968013439DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDKNG2025-12-04
00850068074518TenoviTenovi Co.KNG2025-11-24
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10612479277110McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
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10612479277219McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
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06975725494004MericonnShenzhen Mericonn Technology Co., LtdKNG2024-07-09
GYNXD25000GynexGYNEX CORPORATIONKNG2023-12-20
06951740520133JumperShenzhen Jumper Medical Equipment Co.,Ltd.KNG2023-11-20
06951740520140JumperShenzhen Jumper Medical Equipment Co.,Ltd.KNG2023-11-20
00860005571987Neeva BabySebe IncKNG2023-04-24