FDA UDI
In Commercial Distribution
🇺🇸 United States
Monarch™ System
DI: 00887761019867
·
Model: 1000
·
HILL-ROM SERVICES PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
12
Pkg Device Count
1
Basic Information
- Brand Name
- Monarch™ System
- Primary DI
- 00887761019867
- Version / Model
- 1000
- 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
- 2017-05-08
- Public Version
- 3
- Public Version Date
- 2020-03-18
- Public Version Status
- Update
- Public Device Record Key
- 8a0ef9f0-eb94-4ff4-b825-e666dfcd2049
Device Description
Respiratory Care
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 | 00887761019867 | GS1 | ||||
| Package | 00887761981522 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00887761981539 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00887761981546 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00887761981553 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00887761981607 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00887761981577 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00887761981584 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00887761981591 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00887761981560 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00887761981621 | GS1 | 1 | In Commercial Distribution | ||
| Package | 00887761981614 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)445-3730
- [email protected]