FDA.reportPublic FDA data

VCOMIN Fetal Doppler

Primary DI
06970442090362
Brand
VCOMIN Fetal Doppler
Company
Vcomin Technlogy Limited
Model
FD-290G
Published
2021-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K182526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182526000Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)Vcomin Technology Limited2019-05-29KNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16970442090369PackageGS130In Commercial Distribution
06970442090362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697044209036916970442090369
06970442090362069704420903626970442090362

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.

Regulatory Flags#

DUNS number
548312355
Device count
1
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970442090003VCOMIN Fetal DopplerFD-540B2020-11-24
06970442090034VCOMIN Fetal DopplerFD-231D2020-11-25
06970442090263VCOMIN Fetal DopplerFD-540G2020-11-25
06970442090270VCOMIN Fetal DopplerFD-540D2020-11-25
06970442090287VCOMIN Fetal DopplerFD-540C2020-11-25
06970442090294SpringBud Fetal DopplerFD-500B2020-11-25
06970442090300SpringBud Fetal DopplerFD-500G2020-11-25
06970442090317My Baby's Heartbeat Bear Fetal DopplerFD-590B2020-11-25
06970442090324My Baby's Heartbeat Bear Fetal DopplerFD-590G2020-11-25
06970442090331VCOMIN Fetal DopplerFD-260B2021-05-08
06970442090348VCOMIN Fetal DopplerFD-260G2021-05-08
06970442090355VCOMIN Fetal DopplerFD-290B2021-05-08
06970442090379VCOMIN Fetal DopplerFD-570B2021-05-08
06970442090386VCOMIN Fetal DopplerFD-570G2021-05-08
06970442090393SOYES Fetal DopplerFD-570B2021-05-08
06970442090409SOYES Fetal DopplerFD-570G2021-05-08
06970442090423Fetal Doppler FD-530GFD-530G2021-09-14
06970442090416Fetal Doppler FD-530BFD-530B2021-09-14
06970442090430Fetal Doppler FD-640GFD-640G2021-09-15
00697044209003VCOMIN Fetal DopplerFD-231D2020-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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10612479277110McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
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