SIMEOX 200

Primary DI
03664224000184
Brand
SIMEOX 200
Company
PHYSIO-ASSIST
Model
ACD-200
Device description
Simeox 200 Airway Clearance Device
Published
2025-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SDTIntra-Pulmonary Percussive Vibration (Ipv) Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDTIntra-Pulmonary Percussive Vibration (Ipv) DevicesAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664224000184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664224000184036642240001843664224000184

GMDN Terms#

Term, Definition table
TermDefinition
Vacuum-assisted airway secretion-clearing systemA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
264454301
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664224000023TUB10TUB-102025-08-25
03664224000092SIMEOX 200ACD-200B2025-08-25
03664224000177TUB25TUB-252025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03664224000023TUB10PHYSIO-ASSISTSDT2025-08-25
03664224000092SIMEOX 200PHYSIO-ASSISTSDT2025-08-25
36642240000232TUB10Inogen, Inc.SDT2025-03-12
36642240000928SIMEOX 200Inogen, Inc.SDT2025-03-12
36642240001604SIMEOXInogen, Inc.SDT2025-03-12
36642240001772TUB25Inogen, Inc.SDT2025-03-12
36642240001840SIMEOX 200Inogen, Inc.SDT2025-03-12