FDA.reportPublic FDA data

Imex Pocket Dop II Doppler System

Primary DI
00860011754510
Brand
Imex Pocket Dop II Doppler System
Company
IMEX, LLC
Model
Pocket Dop II
Catalog number
XPA002
Device description
Imex Pocket Dop II system main unit, Imex Dop-Tone II
Published
2026-05-13
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
00860011754510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011754510008600117545108600117545100860011754510

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
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
00850067960058Imex DOPPLER PROBE, 2MHZ, H2O PROOF PDIIWP20WP202026-05-18
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
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
00850067960058Imex DOPPLER PROBE, 2MHZ, H2O PROOF PDIIIMEX, LLCKNG2026-05-18
00850067960041Imex 2MHZ Doppler Probe PD2IMEX, 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
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10612479277165McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
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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
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