DeVilbiss

Basic Information

• Brand Name: DeVilbiss
• Primary DI: 00853040015080
• Version / Model: 3655PL-JCMH
• Catalog Number: 3655PL-JCMH
• Company Name: DEVILBISS HEALTHCARE LLC
• Labeler DUNS: 962175894
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 5
• Public Version Date: 2024-01-25
• Public Version Status: Update
• Public Device Record Key: 3a180883-dae7-4011-a897-0196abb23655
• Distribution End Date: 2024-01-24

Device Description

Compressor / Nebulizer JCMH Home Health Products

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: Yes
• 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
BTI	Compressor, Air, Portable	Anesthesiology	868.6250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31253	Medical device air compressor	A mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853040015080	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K020932	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: – 95 Percent (%) Relative Humidity