FDA UDI
In Commercial Distribution
🇺🇸 United States
SIMEOX 200
DI: 03664224000092
·
Model: ACD-200B
·
PHYSIO-ASSIST
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SIMEOX 200
- Primary DI
- 03664224000092
- Version / Model
- ACD-200B
- Company Name
- PHYSIO-ASSIST
- Labeler DUNS
- 264454301
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-25
- Public Version
- 1
- Public Version Date
- 2025-09-02
- Public Version Status
- New
- Public Device Record Key
- cf896156-993c-4894-bfd1-c5b89c1993c8
Device Description
Simeox 200 airway clearance device with installed battery
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
- 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 | 03664224000092 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius