SIMEOX 200

Basic Information

• Brand Name: SIMEOX 200
• Primary DI: 36642240000928
• Version / Model: SIMEOX-2 B
• Catalog Number: ACD-200B
• Company Name: Inogen, Inc.
• Labeler DUNS: 136729634
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-12
• Public Version: 3
• Public Version Date: 2025-08-20
• Public Version Status: Update
• Public Device Record Key: a24e1e76-1221-4dd0-9ece-ce336100c60f
• Distribution End Date: 2025-03-12

Device Description

Simeox 200 airway clearance device with installed battery, remote control, power supply, transport bag and user manual

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: MR Unsafe
• Direct Marking Exempt: Yes
• 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
SDT	Intra-Pulmonary Percussive Vibration (Ipv) Devices	Anesthesiology	868.5665	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	36642240000928	GS1

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius