Drive

Basic Information

• Brand Name: Drive
• Primary DI: 00822383509136
• Version / Model: 18610
• Company Name: Drive Devilbiss Healthcare
• Labeler DUNS: 867673159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e69a9f91-94ad-4636-9f61-f92d885efd8e

Device Description

Plus Suction Machine

Device Characteristics

• Single Use: No
• 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: 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
JCX	APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED	General, Plastic Surgery	878.4780	2
BTA	PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36787	Thoracic suction system	An assembly of devices designed to evacuate large volumes of fluid and/or air accumulated between the lung and chest wall (pleural space) by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system is usually employed following thoracic surgery, traumatic chest wounds, barotrauma, or pleural effusions. This is a single-use device.	No	Obsolete
10216	Nasal suction system	An assembly of devices designed to evacuate obstructive secretions, gas, liquids (e.g., blood, vomitus), and/or foreign bodies from the upper respiratory tract (i.e., the nasal cavities and oropharynx). It generally consists of mains electricity (AC-powered) suction pump, a pressure regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The typical vacuum level is low; free flow rates may be as high as 30 L/min. The system is used mainly in physician offices and for emergency procedures.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10822383509133	GS1		2	In Commercial Distribution
Primary	00822383509136	GS1

Premarket Submissions

Submission Number	Supplement Number
K102626	000