DEBRIDEMENT SUCKER

Basic Information

• Brand Name: DEBRIDEMENT SUCKER
• Primary DI: B0662010640000
• Version / Model: 201064-000
• Catalog Number: 201064-000
• Company Name: NOVOSCI CORP.
• Labeler DUNS: 938289980
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-06
• Public Version: 4
• Public Version Date: 2023-06-20
• Public Version Status: Update
• Public Device Record Key: 525cae2c-ba0f-4367-8bd6-712b796210ee

Device Description

An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a suction pump powered by compressed air or oxygen from a hospital's central gas system, tubing, plastic/glass collection container(s), a vacuum gauge, a regulator, an overflow trap, a moisture filter, and possibly a microbial filter. The pressurized gas enables the pump to create a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of hospital or other healthcare settings.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Cardiovascular	870.4420	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63649	General-purpose surgical suction system, vacuum	An assembly of vacuum-powered devices, which includes a surgically invasive component, designed to aspirate unwanted materials (e.g., debris, tissues, fluids) from body cavities/wounds during a surgical procedure (e.g., general surgery, laparoscopy); it may in addition have non-surgical applications. It is connected via dedicated tubing to the terminal unit (wall outlet) of a vacuum pipeline system and relies on the healthcare facility’s central vacuum system. It includes a vacuum suction regulator which controls negative pressure for the aspiration, collection containers, and patient contact devices (e.g., handpiece/tip); it typically also includes tubing and microbial/hydrophobic filters.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B0662010640005	HIBCC	OUTER SHIPPER	100	In Commercial Distribution
Primary	B0662010640000	HIBCC
Package	B0662010640003	HIBCC	INNER CARTON	25	In Commercial Distribution
Package	B0662010640007	HIBCC	PARTIAL CASE	75	In Commercial Distribution
Package	B0662010640006	HIBCC	PARTIAL CASE	50	In Commercial Distribution

Customer Contacts

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