Spectra

Primary DI
28809108017783
Brand
Spectra
Company
UZINMEDICARE CO.,LTD
Model
Spectra Wearable power adapter plug
Catalog number
MM55PRONGS
Device description
Plug in the Spectra wearable adapter
Published
2025-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
28809108017783PackageGS150In Commercial Distribution
08809108017789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880910801778328809108017783
08809108017789088091080177898809108017789

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688451947
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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