FDA.reportPublic FDA data

Imex DOPPLER PROBE, 2MHZ, H2O PROOF PDII

Primary DI
00850067960058
Brand
Imex DOPPLER PROBE, 2MHZ, H2O PROOF PDII
Company
IMEX, LLC
Model
WP20
Catalog number
WP20
Device description
Imex DOPPLER PROBE, 2MHZ, H2O PROOF PDII
Published
2026-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K901593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901593000IMEX DOP-TONE IIImex Medical Systems, Inc.1990-07-02KNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850067960058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850067960058008500679600588500679600580850067960058

GMDN Terms#

Term, Definition table
TermDefinition
Foetal Doppler system probeA hand-operated component of a foetal Doppler system intended to be placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device.

Regulatory Flags#

DUNS number
119901967
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850067960003Imex 5MHZ DOPPLER PROBE, PD2T500T5002026-05-18
00850067960010Imex ELITE 3MHZ OB PROBEN300N3002026-05-18
00850067960027Imex 8MHZ DOPPLER PROBE, PD2T800T8002026-05-18
00850067960034Imex 3MHZ DOPPLER PROBE,PD2T300T3002026-05-18
00860011754565Imex ELITE 2MHZ WATERPROOF PROBE V2NW20NW202026-05-18
00860011754572Imex ELITE 2MHZ OB PROBEN200N2002026-05-18
00860011754589Imex ELITE 8MHZ VASCULAR PROBEN800N8002026-05-18
00860011754596Elite 5 MHz Vascular ProbeN5002026-05-18
00850067960041Imex 2MHZ Doppler Probe PD2T200T2002026-05-13
00860011754503Imex Elite 200 DopplerElite 200XMD0072026-05-13
00860011754510Imex Pocket Dop II Doppler SystemPocket Dop IIXPA0022026-05-13
00860011754527Imex Elite 100 DopplerElite 100XMD0102026-05-13
00860011754534Imex CT+ DopplerCT+XLT0092026-05-13
00860011754541Imex Elite 200R DopplerElite 200RXMD0082026-05-13
00860011754558Imex Elite 100R DopplerElite 100RXMD0112026-05-13

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
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
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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
06975725492000MericonnShenzhen Mericonn Technology Co., LtdKNG2023-02-16