Spectra

Basic Information

• Brand Name: Spectra
• Primary DI: 08809108014405
• Version / Model: Spectra accessory (CaraCups Backflow Protector Replacement Kit)
• Company Name: UZINMEDICARE CO.,LTD
• Labeler DUNS: 688451947
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2021-07-12
• Public Version: 1
• Public Version Date: 2021-07-20
• Public Version Status: New
• Public Device Record Key: af9844e5-7222-4d89-8249-f25aa93df52a

Device Description

A collection of non-sterile items intended to be used in conjunction with the electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. This is a reusable device.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: Yes
• Has Serial Number: No
• 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
61734	Breast pump support kit, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	28809108014409	GS1	Carton box	200	In Commercial Distribution
Primary	08809108014405	GS1
Unit of Use	08809108014528	GS1

Customer Contacts

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