FDA.reportPublic FDA data

Spectra

Primary DI
08809108017437
Brand
Spectra
Company
UZINMEDICARE CO.,LTD
Model
Spectra Handy Plus
Catalog number
MM010964
Device description
A hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGYPump, Breast, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGYPump, Breast, Non-PoweredObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28809108017431PackageGS130In Commercial Distribution
08809108017437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880910801743128809108017431
08809108017437088091080174378809108017437

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, manualA hand-held device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a low-grade suction through a funnel-like component that is applied to the breast and is typically operated by the donor; the milk collects in an attached vessel (e.g., a sterilized bottle). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+821053081195shahn@uzinmedical.co.kr

Regulatory Flags#

DUNS number
688451947
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809108020017SpectraSpectra accessory kit(20mm shield set)MM012340-20mm2026-04-30
08809108020024SpectraSpectra accessory kit(24mm shield set)MM012340-24mm2026-04-30
08809108018496SpectraSpectra accessory kit(24mm shield set)MM012340-24mm2026-01-23
00889108018496SpectraSpectra accessory kit(24mm shield set)MM012340-24mm2025-10-15
08809108019912SpectraBreast milk storage bottle packageMM0119002026-02-27
28809108019916SpectraBreast milk storage bottle packageMM0119002026-02-27
08809108019684SpectraSpectra S3 ProMM10035-H2026-02-03
08809108019691SpectraSpectra 9 PlusMM0113432026-02-03
08809108019707SpectraSpectra Synergy GoldMM0114002026-02-03
08809108019714SpectraSpectra SG gold portableMM0114502026-02-03
08809108019769SpectraSpectra accessory kit(20mm shield set)MM012340-20mm2026-02-03
08809108019776SpectraSpectra accessory kit(24mm shield set)MM012340-24mm2026-02-03
08809108019783SpectraSpectra accessory kit(28mm shield set)MM012340-28mm2026-02-03
08809108019790SpectraSpectra accessory kit(32mm shield set)MM012340-32mm2026-02-03
08809108019820SpectraSpectra PP bottle setMM0119092026-02-03
28809108019688SpectraSpectra S3 ProMM10035-H2026-02-03
28809108019695SpectraSpectra 9 PlusMM0113432026-02-03
28809108019701SpectraSpectra Synergy GoldMM0114002026-02-03
28809108019718SpectraSpectra SG gold portableMM0114502026-02-03
28809108019763SpectraSpectra accessory kit(20mm shield set)MM012340-20mm2026-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420060215045haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215052haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215083haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215090haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215106haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215113haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215120haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060215137haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060216011haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060216028haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060216035haakaaTHINK GREEN LIMITEDHGY2026-09-21
09420060214123haakaaTHINK GREEN LIMITEDHGY2026-09-20
09420060214130haakaaTHINK GREEN LIMITEDHGY2026-09-20
09420060214147haakaaTHINK GREEN LIMITEDHGY2026-09-20
09420060214154haakaaTHINK GREEN LIMITEDHGY2026-09-20
09420060201055haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201062haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201079haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201086haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201093haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201680haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201697haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201703haakaaTHINK GREEN LIMITEDHGY2026-09-18
09420060201710haakaaTHINK GREEN LIMITEDHGY2026-09-18
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06925546001981ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGY2026-07-28
06925546020814ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGY2026-07-28
06925546002087Figaroo™ GlideCixi Ruihong Electric Appliance Co., Ltd.HGY2026-07-23
08809108019097SpectraUZINMEDICARE CO.,LTDHGY2025-10-15
00810104130936 Wave Single Manual Pump KitWILLOW INNOVATIONS, INC.HGY2025-07-23