SSCOR Duet ®

Basic Information

• Brand Name: SSCOR Duet ®
• Primary DI: B2452314NB0
• Version / Model: 2314NB
• Company Name: SSCOR, INC.
• Labeler DUNS: 131254971
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-22
• Public Version: 1
• Public Version Date: 2019-08-30
• Public Version Status: New
• Public Device Record Key: b6cc7582-40fc-4a1d-8d6a-c2eb203171fc

Device Description

Portable Suction Device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
BTA	Pump, Portable, Aspiration (Manual Or Powered)	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47366	Emergency airway clearance suction system, electric	A portable assembly of devices, which includes a non-surgical invasive component, intended to aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes an electrically-powered suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B2452314NB1	HIBCC	Carton	1	In Commercial Distribution
Primary	B2452314NB0	HIBCC