FDA.reportPublic FDA data

Spectra

Primary DI
08809108017901
Brand
Spectra
Company
UZINMEDICARE CO.,LTD
Model
Spectra Wearable power adapter
Catalog number
MM550002-S
Device description
Power adapter for Spectra wearable
Published
2025-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
28809108017905PackageGS1100In Commercial Distribution
08809108017901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880910801790528809108017905
08809108017901088091080179018809108017901

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
08809444071049HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071056HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071223HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071230HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071339HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071346HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071353HaenimHaenim Co.,Ltd.HGX2026-06-05
08809444071360HaenimHaenim Co.,Ltd.HGX2026-06-05
06976313750014AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750021AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750212AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750229AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750236AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750649AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750656AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
06976313750663AOJShenzhen AOJ Health Science & Technology Co., Ltd.HGX2026-06-03
08809108020017SpectraUZINMEDICARE CO.,LTDHGX2026-04-30
08809108020024SpectraUZINMEDICARE CO.,LTDHGX2026-04-30
19551028430006AmedaTPH TECHNOLOGY MALAYSIA SDN. BHD.HGX2026-03-03
07640108054975Ardo MeliaArdo medical AGHGX2026-02-27
08809108019912SpectraUZINMEDICARE CO.,LTDHGX2026-02-27
16973493597344TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493599430TPHShenzhen TPH Technology Co., LtdHGX2026-02-27
16973493592226MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493592431lansinoh Shenzhen TPH Technology Co., LtdHGX2026-02-25
16973493592530MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493593995MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493594244MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493594374MommedShenzhen TPH Technology Co., LtdHGX2026-02-25
16973493597078MommedShenzhen TPH Technology Co., LtdHGX2026-02-25