FDA.reportPublic FDA data

Spectra

Primary DI
08809108017918
Brand
Spectra
Company
UZINMEDICARE CO.,LTD
Model
Spectra Wearable power adapter plug
Catalog number
MM55PRONGS
Device description
Plug in the Spectra wearable adapter
Published
2025-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K220926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220926000Spectra WearableUzinmedicare Co., Ltd.2022-12-12HGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28809108017912PackageGS1800In Commercial Distribution
08809108017918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880910801791228809108017912
08809108017918088091080179188809108017918

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Regulatory Flags#

DUNS number
688451947
Device count
1
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