FDA UDI
In Commercial Distribution
🇺🇸 United States
The Vest®System
DI: 00887761997752
·
Model: 105000
·
HILL-ROM SERVICES PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- The Vest®System
- Primary DI
- 00887761997752
- Version / Model
- 105000
- Company Name
- HILL-ROM SERVICES PTE. LTD.
- Labeler DUNS
- 595156263
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 5
- Public Version Date
- 2021-01-18
- Public Version Status
- Update
- Public Device Record Key
- 6f4ba065-38c4-4c7c-a5c3-25a8abb65f0e
Device Description
Respiratory Care
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
- 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 |
|---|---|---|---|---|
| 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 | 00887761997752 | GS1 |
Customer Contacts
- Phone
- +1(800)445-3730
- [email protected]