Spectra

Primary DI
28809108012467
Brand
Spectra
Company
Uzinmedicare
Model
Spectra accessory (Accessory Kit for S1&S2 ( 20mm
Device description
A collection of non-sterile items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.
Published
2019-03-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGXPump, Breast, Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28809108012467PackageGS150In Commercial Distribution
08809108013347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880910801246728809108012467
08809108013347088091080133478809108013347

GMDN Terms#

Term, Definition table
TermDefinition
Breast pump support kit, reusableA collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
688451947
Device count
1
DM exempt
false
Premarket exempt
true
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
18809108011364SpectraSpectra Synergy2020-04-30
28809108011583SpectraSpectra accessory (Accessory Kit_Manual switch)2019-10-19
28809108012825SpectraSpectra accessory(24mm Breast shield) 2019-04-05
28809108012832SpectraSpectra accessory (28mm Breast shield)2019-04-05
28809108012849SpectraSpectra accessory(32mm Breast shield)2019-04-05
28809108011316SpectraSpectra S3 Pro2019-03-22

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