FDA.reportPublic FDA data

N/A

Primary DI
06972040110534
Brand
N/A
Company
Shenzhen AOJ Medical Technology Co., Ltd
Model
AOJ-50C
Published
2021-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K182190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182190000Fetal DopplerShenzhen AOJ Medical Technology Co., Ltd.2018-12-19KNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972040110534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972040110534069720401105346972040110534

GMDN Terms#

Term, Definition table
TermDefinition
Foetal cardiac monitorA mains electricity (AC-powered) device designed to detect, measure, and display foetal heart activity during the perinatal period. Typically foetal heart rate is measured, but heart valve movement can also be assessed. The device operates noninvasively by: 1) electronically registering and graphically presenting foetal heart sounds; 2) discriminating foetal and maternal electrocardiographic signals obtained from the maternal abdomen with external electrodes; or 3) transmitting and receiving ultrasonic energy into and from the pregnant woman usually by means of continuous wave (Doppler) echoscopy. The device may include an alarm that signals when the heart rate crosses a pre-set threshold.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554409093
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972040117540N/AAOJ-F1062026-03-26
06972040117557N/AAOJ-F1072026-03-26
06972040110800N/AAOJ-35A2026-03-25
06972040110978N/AAOJ-35G2026-03-25
06972040111029N/AAOJ-F1022026-03-25
06972040111296N/AAOJ-35F2026-03-25
06972040111418N/AARM-30H2026-03-25
06972040111494N/AARM-30J2026-03-25
06972040111654N/AWRS-35H2026-03-25
06972040112002N/AARM-30K2026-03-25
06972040112019N/AARM-90B2026-03-25
06972040112026N/AWRS-35K2026-03-25
06972040112033N/AWRS-35N2026-03-25
06972040112071N/AAOJ-F1012026-03-25
06972040112088N/AAOJ-F1032026-03-25
06972040112590N/AWRS-35S2026-03-25
06972040113801N/AWRS-35P2026-03-25
06972040117526N/AAOJ-F1042026-03-25
06972040117533N/AAOJ-F1052026-03-25
06972040110572N/AAOJ-35B2021-01-13

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
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