FDA.reportPublic FDA data

Spectra

Primary DI
08809108019059
Brand
Spectra
Company
UZINMEDICARE CO.,LTD
Model
Spectra S3 Pro
Catalog number
MM10035-H
Device description
This is powered breast pump to be used by lactating women to express and collect milk from their breasts.The final product is packed in a box with neccessary connecting parts including breast shield, tubing, back-flow protector, silicone valve, bottle set, adapter and instruction for use, so the user can use the device right after receving them.
Published
2025-10-15
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
HGXPump, Breast, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGXPump, Breast, PoweredObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181784000Spectra S3 PlusUzinmedicare Co.2018-11-30HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28809108019053PackageGS12In Commercial Distribution
08809108019059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880910801905328809108019053
08809108019059088091080190598809108019059

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump, electricA mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+821099269027ghwns57@uzinmedicare.com

Regulatory Flags#

DUNS number
688451947
Device count
1
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
07640108055903Breast shell sterile DeTach 12 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055927Breast shell sterile DeTach 13 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055941Breast shell sterile DeTach 14 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055965Breast shell sterile DeTach 15 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055989Breast shell sterile DeTach 16 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108056009Breast shell sterile DeTach 17 mm (2 pcs)Ardo medical AGHGX2026-07-31
07640108055545Breast shell sterile DeTach 18 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055569Breast shell sterile DeTach 21 mm (2 pcs)Ardo medical AGHGX2026-07-30
07640108055583Breast shell sterile DeTach 24 mm (2 pcs)Ardo medical AGHGX2026-07-30
06925546002285ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06925546003381ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06925546033821ZimeituCixi Ruihong Electric Appliance Co., Ltd.HGX2026-07-28
06937266900017FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900024FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900031FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900048FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900055FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900062FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900079FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900086FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900093FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900109FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900116FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900123FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
06937266900130FatonePOLYBELL (GUANGZHOU) LIMITEDHGX2026-07-23
00020451906065Pump In Style Pro+ w/HarmonyMedela LLCHGX2026-07-20
00810104131018Willow Sync 5oz Container SetWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131025Willow Sync Container Back ReplacementWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131032Willow Sync Duckbill ValvesWILLOW INNOVATIONS, INC.HGX2026-07-16
00810104131049Willow Sync DiaphragmsWILLOW INNOVATIONS, INC.HGX2026-07-16