FDA.reportPublic FDA data

MedOne

Primary DI
00864243000414
Brand
MedOne
Company
MEDONE LLC
Model
JPD-200S
Device description
Fetal Heartbeat Monitor
Published
2017-09-21
Public version status
Update
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
K110124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110124000FETAL DOPPLER JPD-100SShenzhen Jumper Medical Equipment Co., Ltd.2011-02-04KNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864243000414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864243000414008642430004148642430004140864243000414

GMDN Terms#

Term, Definition table
TermDefinition
Foetal Doppler system probeA hand-operated component of a foetal Doppler system which is 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080800987
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864243000421MedOneJPD-FR4082017-09-21
00864243000445MedOneJPD-900A2019-01-18
00864243000407MedOneJPD-900W2017-09-21

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