FDA.reportPublic FDA data

ES102EX

Primary DI
00894912002173
Brand
ES102EX
Company
KOVEN TECHNOLOGY, INC.
Model
ES102EX
Catalog number
ES102EX
Device description
Fetal Echosounder Doppler
Published
2016-02-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNGMonitor, Ultrasonic, Fetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNGMonitor, Ultrasonic, FetalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894912002173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894912002173008949120021738949120021730894912002173

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

Contacts#

Phone, Email table
PhoneEmail
314-542-2101info@koven.com

Regulatory Flags#

DUNS number
069261402
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894912002180DVM 4500DVM 4500DVM 45002016-03-10
00894912002302BT10M5S8ABT10M5S8ABT10M5S8A2016-03-10
00894912002319BT10M5S8CBT10M5S8CBT10M5S8C2016-03-10
00894912002333BT5M05S8ABT5M05S8ABT5M05S8A2016-03-10
00894912002340BT5M05S8CBT5M05S8CBT5M05S8C2016-03-10
00894912002357BT8M05S8ABT8M05S8ABT8M05S8A2016-03-09
00894912002364BT8M05S8CBT8M05S8CBT8M05S8C2016-03-10
00894912002425T10M5S8CT10M5S8CT10M5S8C2016-03-10
00894912002449T5M05S8CT5M05S8CT5M05S8C2016-03-10
00894912002456T8M05S8CT8M05S8CT8M05S8C2016-03-10
00894912002975BT5M05S8ABT5M05S8ABT5M05S8A2016-07-06
00894912002432T2M20S8CT2M20S8CT2M20S8C2016-03-10
00894912002463T2M25N8AT2M25N8AT2M25N8A2016-03-10
00894912002876Pencil probeBP5M05S8ABP5M05S8A2016-06-29
00894912002890Pencil probeBP10M5S8ABP10M5S8A2016-06-29
00894912002883Pencil probeBP8M05S8ABP8M05S8A2018-04-10
00894912002036CTCT-4CT-42020-04-03
00894912002326BT2M20S8CBT2M20S8CBT2M20S8C2016-03-10
00894912002067PAUS2.0PAUS2.02025-01-01
00894912002043BiDop 3BiDop 3ES-100V3 2016-02-24

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
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
06975725493007MericonnShenzhen Mericonn Technology Co., LtdKNG2024-07-09
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