FDA.reportPublic FDA data

FaceLake

Primary DI
00851908007116
Brand
FaceLake
Company
LORTE TECHNOLOGIES, INC
Model
FD-200P
Device description
The FD-200P is a ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart rate.
Published
2018-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true

Contact Domains#

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
00851908007116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851908007116008519080071168519080071160851908007116

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
1-847-234-0754info@fetaldoppler.net

Regulatory Flags#

DUNS number
029578633
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851908007055FaceLakeCMS-60D2016-10-27
00851908007000FaceLakeFL-3502016-10-25
00851908007017FaceLakeFL-4002016-10-25
00851908007024FaceLakeCMS-50D Plus2016-10-27
00851908007123FaceLakeFL-4202018-01-17
00851908007222FaceLakeFT822020-12-09
00851908007031FaceLakeCMS-50E2016-10-27
00851908007062FaceLakeCMS-50EW with Bluetooth2016-10-27
00851908007079FaceLakeCMS-50F2016-10-27
00851908007086FaceLakeFL-1002017-03-02
00851908007048FaceLakeSonoline B2016-10-27
00851908007093FaceLakeFL-100B2017-03-02
00851908007109FaceLakeFD-200B2018-01-17
00851908007130FaceLakeFD-300P2018-03-21
00851908007161FaceLakeFD-300B2018-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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10612479277165McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
10612479277172McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
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10612479277219McKessonMCKESSON MEDICAL-SURGICAL INC.KNG2025-06-16
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