DRIVE

Basic Information

• Brand Name: DRIVE
• Primary DI: 00822383541709
• Version / Model: MQ6003NEU
• Company Name: Drive Devilbiss Healthcare
• Labeler DUNS: 867673159
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-07
• Public Version: 3
• Public Version Date: 2024-03-01
• Public Version Status: Update
• Public Device Record Key: 445ee171-ed50-4c6f-a89a-522dd22ff80a
• Distribution End Date: 2024-02-29

Device Description

Respiratory Nebs Product Description Panda Compressor Neb 220v 1/ea, 6/cv

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: Yes
• 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
CAF	Nebulizer (direct patient interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44705	Inhalation-therapy adaptor, reusable	A small connecting device, usually with a small channel, intended to join a sterile water pack or a sterile isotonic sodium chloride solution pack to an inhalation therapy device (e.g., humidifier, nebulizer, oxygen therapy delivery system) when the connection is not compatible (e.g., when the humidifier and the sterile water pack are of different manufacture). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00822383541709	GS1

Premarket Submissions

Submission Number	Supplement Number
K031413	000