FDA.reportPublic FDA data

Baby Doppler

Primary DI
00628055787013
Brand
Baby Doppler
Company
DAGAMMA INC.
Model
Sonoline B Blue 3MHz
Device description
The Sonoline B Fetal Doppler is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart rate.
Published
2017-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true

Contact Domains#

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
K082480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082480000CONTEC POCKET FETAL DOPPLERContec Medical System Co., Ltd.2009-02-25KNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055787013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055787013006280557870136280557870130628055787013

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005902767support@dagamma.com

Regulatory Flags#

DUNS number
080572190
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055787389DagammaFinger Pulse Oximeter DP-100 Blue2017-03-30
00628055787396DagammaFinger Pulse Oximeter DP-100 Black2017-03-30
00628055787402DagammaFinger Pulse Oximeter DP-100 White2017-03-30
00628055787426DagammaFinger Pulse Oximeter DP-100 Yellow2017-03-30
00628055787433DagammaFinger Pulse Oximeter DP-100 Pink2017-03-30
00628055787570DagammaFinger Pulse Oximeter DP-150 Blue2017-10-06
00628055787587DagammaFinger Pulse Oximeter DP-150 Black2017-10-06
00628055787594DagammaFinger Pulse Oximeter DP-150 White2017-10-06
00628055787617DagammaFinger Pulse Oximeter DP-150 Yellow2017-10-06
00628055787624DagammaFinger Pulse Oximeter DP-150 Pink2017-10-06
00628055787457DagammaFinger Pulse Oximeter DP2502020-05-28
00628055787440DagammaFinger Pulse Oximeter DP2002020-05-28
10628055787454DagammaFinger Pulse Oximeter DP2502020-05-28
00628055787839BabyTemp by Baby DopplerDuoSmart Thermometer2020-05-28
00628055787242Baby DopplerBabyTemp 1 Sec ThermometerAL65005002019-05-23
00628055787259DagammaDT10002017-03-30
00628055787051Baby DopplerSonoline B Pink 3MHz2017-03-30
00628055787266Baby DopplerUltraline 1000 Blue 2.5MHz2017-09-28

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
10612479277103McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
10612479277110McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
10612479277127McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
10612479277134McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
10612479277141McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
10612479277158McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
10612479277165McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
10612479277172McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
10612479277189McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
10612479277196McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
10612479277202McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
10612479277219McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
06945040109914CONTECContec Medical Systems Co., Ltd.KNG2024-07-16
06945040109938CONTECContec Medical Systems Co., Ltd.KNG2024-07-16
06945040109952CONTECContec Medical Systems Co., Ltd.KNG2024-07-16
06975725491003MericonnShenzhen Mericonn Technology Co., LtdKNG2024-07-09
06975725493007MericonnShenzhen Mericonn Technology Co., LtdKNG2024-07-09
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