Spectra

Basic Information

• Brand Name: Spectra
• Primary DI: 08809108016461
• Version / Model: Spectra SG Portable
• Company Name: UZINMEDICARE CO.,LTD
• Labeler DUNS: 688451947
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-15
• Public Version: 1
• Public Version Date: 2024-01-23
• Public Version Status: New
• Public Device Record Key: dd33b6ea-2c18-4338-bb79-5214dedd86df

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(flange), Silicone valve, tubing, backflow protector, bottle, and instruction for use, so the user can use the device right after receving them.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	884.5160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38478	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28809108016465	GS1	Carton box	2	In Commercial Distribution
Primary	08809108016461	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K210124	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 95 Percent (%) Relative Humidity