FDA.reportPublic FDA data

VCOMIN Fetal Doppler

Primary DI
16970442090000
Brand
VCOMIN Fetal Doppler
Company
Vcomin Technlogy Limited
Model
FD-540B
Published
2020-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
16970442090000PackageGS130Not in Commercial Distribution
06970442090003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697044209000016970442090000
06970442090003069704420900036970442090003

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

Regulatory Flags#

DUNS number
548312355
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06970442090362VCOMIN Fetal DopplerFD-290G2021-05-08
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

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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