FDA.reportPublic FDA data

Clinical Guard

Primary DI
00897429002513
Brand
Clinical Guard
Company
Clinical Guard
Model
Sonoline B
Published
2017-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K082480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082480000CONTEC POCKET FETAL DOPPLERContec Medical System Co., Ltd.2009-02-25KNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10897429002510PackageGS160In Commercial Distribution
00897429002513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089742900251010897429002510
00897429002513008974290025138974290025130897429002513

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
827033924
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851950008161Virginia National Guard50DL-BContec2018-01-15
00851950008048ArvolifeFertility Kit2018-03-27
00897429002704Clinical GuardLH40 and HCG 10 Combo2017-12-19
10897429002701Clinical GuardLH40 and HCG 10 Combo2017-12-19
00897429002766Clinical GuardOvulation Urine Test Strip Pack of 502017-12-19
00851950008123ArvolifeTHC Marijuana Drug Test Strip2018-03-27
00851950008147ArvolifeDrug Test Panel2018-03-27
00851950008154ArvolifeDrug Test Cup2018-03-26
00897429002230Clinical GuardCMS50E2017-12-06
00897429002469Clinical GuardCMS500S2017-03-30
00897429002520Clinical GuardCMS 50DL2017-06-08
00897429002971Clinical GuardCMS50F2017-12-06
10897429002237Clinical GuardCMS50E2017-12-06
20897429002463Clinical GuardCMS500S2017-03-30
00897429002476Clinical GuardAero22017-08-02
20897429002524Clinical GuardCMS 50DL2017-06-08
10897429002978Clinical GuardCMS50F2017-12-06
00897429002056OctiveTechFDIR-V12016-10-04
20851950008165Virginia National Guard50DL-BContec2018-01-15
00851950008130ArvolifeHCG Midstream2018-03-27

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