FDA UDI
In Commercial Distribution
🇺🇸 United States
LibAirty Airway Clearance System Vest (S)
DI: 07290020062017
·
Model: L4MV0001
·
SYNCHRONY MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LibAirty Airway Clearance System Vest (S)
- Primary DI
- 07290020062017
- Version / Model
- L4MV0001
- Company Name
- SYNCHRONY MEDICAL LTD
- Labeler DUNS
- 600768341
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-19
- Public Version
- 1
- Public Version Date
- 2025-05-27
- Public Version Status
- New
- Public Device Record Key
- 1e95bce5-041f-4d85-8e3e-33884a28d7be
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
- 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 |
|---|---|---|---|---|
| BYI | Percussor, Powered-Electric | Anesthesiology | 868.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38124 | Chest-oscillation airway secretion-clearing system | An assembly of devices designed to provide high frequency chest wall oscillation (HFCWO) for external chest wall manipulation intended to loosen excessive airway secretions [mucus or sputum (phlegm)] to promote airway clearance and improve bronchial drainage for patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)]. It consists of a mains electricity (AC-powered) oscillating pressurized air generator, an inflatable vest (jacket) to be worn by the patient and a connecting hose. It is intended to be operated by a healthcare professional in a professional setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290020062017 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242063 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | S (small) |