FDA.reportPublic FDA data

Inhealth

Primary DI
06951740522397
Brand
Inhealth
Company
Shenzhen Jumper Medical Equipment Co.,Ltd.
Model
JPD-100S(mini)
Published
2017-09-15
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
06951740522397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06951740522397069517405223976951740522397

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

Regulatory Flags#

DUNS number
529217911
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06951740500593JUMPERHWA202023-11-03
06951740517904JUMPERHWA212023-11-03
06951740500586JUMPERHWA102023-10-31
06951740517898JUMPERHWA112023-10-31
06951740504638JUMPERJPD-ES1002018-03-13
06951740540377THERMOBIOhttps://gudid.fda.gov/gudid/resources/images/icons2025-10-18
06951740540360NOVAPO-3012025-08-07
06951740518147JUMPERJPD-HA201C2025-05-09
06951740520188JUMPERJPD-100E12025-05-09
06951740500562JUMPERHAA102025-04-02
06951740500579JUMPERHAA202025-04-02
06951740517935JUMPERHAA212025-04-02
06951740517942JUMPERHAA112025-04-02
06951740540162JUMPERJPD-510E2024-07-17
06951740520171JUMPERJPD-100F2025-02-07
06951740550192JUMPERJPD-ES2302025-01-17
06951740550277JUMPERLPA112025-01-17
06951740540049pluse oximeterSPA102023-10-20
06951740540056pluse oximeterSPA112023-10-20
06951740540063pluse oximeterSPA202023-10-20

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