Drive DeVilbiss Vacu-Aide Sunciton Unit

Basic Information

• Brand Name: Drive DeVilbiss Vacu-Aide Sunciton Unit
• Primary DI: 00885304032540
• Version / Model: 7325D-D
• Catalog Number: 7325D-D
• Company Name: Drive Devilbiss Healthcare
• Labeler DUNS: 867673159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-07
• Public Version: 2
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: 27a3f5f4-b4f3-4494-9cda-c5b1069a4718

Device Description

Vacu-Aide, North America

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48000	Vacuum-assisted airway secretion-clearing system	A mains electricity (AC-powered) device assembly designed to remove excessive secretion [mucus or sputum (phlegm)] from the lungs and upper airway of patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)] or during cardiac rehabilitation. It consists of an electrical pump connected via a connecting tube to a hand-held venturi valve with attached mouthpiece. It functions through vacuum technology that accelerates the air exhaled by the patient; this helping to loosen the mucus for expectoration. No medication is involved. It may be used in a medical facility or the home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885304032540	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K982304	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 77 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -13 – 140 Degrees Fahrenheit