Home GUDID 28809108011316 Spectra
Primary DI 28809108011316
Brand Spectra
Company Uzinmedicare
Model Spectra S3 Pro
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, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them.
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 Product Codes# Code, Name table Code Name HGX Pump, Breast, Powered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HGX Pump, Breast, Powered Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 18809108011319 Package GS1 1 In Commercial Distribution 28809108011316 Package GS1 2 In Commercial Distribution 08809108011312 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 18809108011319 18809108011319 28809108011316 28809108011316 08809108011312 08809108011312 8809108011312
GMDN Terms# Term, Definition table Term Definition Breast pump, electric A 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 Type Low High Condition Handling Environment Humidity 15 Percent (%) Relative Humidity 93 Percent (%) Relative Humidity Handling Environment Temperature 5 Degrees Celsius 40 Degrees Celsius Storage Environment Humidity 15 Percent (%) Relative Humidity 93 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
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 true 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 DI Brand Model Catalog Published 18809108011364 Spectra Spectra Synergy 2020-04-30 28809108011583 Spectra Spectra accessory (Accessory Kit_Manual switch) 2019-10-19 28809108012825 Spectra Spectra accessory(24mm Breast shield) 2019-04-05 28809108012832 Spectra Spectra accessory (28mm Breast shield) 2019-04-05 28809108012849 Spectra Spectra accessory(32mm Breast shield) 2019-04-05 28809108012467 Spectra Spectra accessory (Accessory Kit for S1&S2 ( 20mm 2019-03-22
Other Devices Sharing Product Codes# 
uzinmedical.co.kr