FDA.reportPublic FDA data

Baby Doppler

Primary DI
00628055787266
Brand
Baby Doppler
Company
DAGAMMA INC.
Model
Ultraline 1000 Blue 2.5MHz
Device description
The Ultraline 1000 is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart rate.
Published
2017-09-28
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
K131457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131457000FETAL ULTRASONIC MONITOR AND ACCESSORIESShenzhen Jumper Medical Equipment Co., Ltd.2014-01-24KNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055787266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055787266006280557872666280557872660628055787266

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
Lot or batch
true
Serial number
true
Manufacturing date on label
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
00628055787013Baby DopplerSonoline B Blue 3MHz2017-03-30
00628055787051Baby DopplerSonoline B Pink 3MHz2017-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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06951740520133JumperShenzhen Jumper Medical Equipment Co.,Ltd.KNG2023-11-20
06951740520140JumperShenzhen Jumper Medical Equipment Co.,Ltd.KNG2023-11-20
00860005571987Neeva BabySebe IncKNG2023-04-24