FDA.reportPublic FDA data

Sweetiesong Pocket Fetal Doppler

Primary DI
00850253007796
Brand
Sweetiesong Pocket Fetal Doppler
Company
EASY HEALTHCARE CORPORATION
Model
EZD-100ST
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KNGMonitor, Ultrasonic, Fetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNGMonitor, Ultrasonic, FetalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850253007793PackageGS160In Commercial Distribution
00850253007796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085025300779310850253007793
00850253007796008502530077968502530077960850253007796

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.

Regulatory Flags#

DUNS number
080278407
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

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00810038638881Easy@Home Smart Basal ThermometerEBT-300 PURPLE2025-07-31
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10810038637157easy@Home PdG Urine Test StripEZW3-SEZW3-S-52025-07-24
10810038638048easy@Home PdG Urine Test StripEZW3-SEZW3-S-102025-07-24
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