FDA.reportPublic FDA data

Imex ELITE 3MHZ OB PROBE

Primary DI
00850067960010
Brand
Imex ELITE 3MHZ OB PROBE
Company
IMEX, LLC
Model
N300
Catalog number
N300
Device description
Imex ELITE 3MHZ OB PROBE
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
JAFMonitor, Ultrasonic, Nonfetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAFMonitor, Ultrasonic, NonfetalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982635000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982635000CAREDOP IINicolet Biomedical1998-08-07JAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850067960010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850067960010008500679600108500679600100850067960010

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
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
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
00860011754565Imex ELITE 2MHZ WATERPROOF PROBE V2IMEX, LLCJAF2026-05-18
00860011754572Imex ELITE 2MHZ OB PROBEIMEX, LLCJAF2026-05-18
00860011754589Imex ELITE 8MHZ VASCULAR PROBEIMEX, LLCJAF2026-05-18
00860011754596Elite 5 MHz Vascular ProbeIMEX, LLCJAF2026-05-18
00860011754503Imex Elite 200 DopplerIMEX, LLCJAF2026-05-13
00860011754527Imex Elite 100 DopplerIMEX, LLCJAF2026-05-13
00860011754534Imex CT+ DopplerIMEX, LLCJAF2026-05-13
00860011754541Imex Elite 200R DopplerIMEX, LLCJAF2026-05-13
00860011754558Imex Elite 100R DopplerIMEX, LLCJAF2026-05-13
08033737710869THD SLIDE ONETHD SPAJAF2025-10-30
18033737710354THD SLIDE ONETHD SPAJAF2025-10-30
08051887047918THD SLIDE ONETHD SPAJAF2025-04-03
18051887047915THD SLIDE ONETHD SPAJAF2025-04-03
B4371194904Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
B4371198605Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
B4371199606Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
B437129500Unetixs Vascular UNETIXS VASCULAR, INC.JAF2023-02-27
18033737710781THD SLIDE ONETHD SPAJAF2022-09-09
08033737710777THD SLIDE ONETHD SPAJAF2022-09-01
18033737710774THD SLIDE ONETHD SPAJAF2022-09-01
05051968044501DOPPLEXHUNTLEIGH HEALTHCARE LIMITEDJAF2022-02-07
00852785008289DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008296DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008340DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008357DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008401DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008418DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008463DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008470DigiDopNEWMAN MEDICAL LLCJAF2021-06-25
00852785008494DigiDopNEWMAN MEDICAL LLCJAF2021-06-25