FDA UDI
In Commercial Distribution
🇺🇸 United States
Large Manual Percussor Cup; 89mm
DI: 00858409005627
·
Model: MC-2289
·
Medicomp
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Large Manual Percussor Cup; 89mm
- Primary DI
- 00858409005627
- Version / Model
- MC-2289
- Catalog Number
- MC-2289
- Company Name
- Medicomp
- Labeler DUNS
- 154454730
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-22
- Public Version
- 1
- Public Version Date
- 2020-04-30
- Public Version Status
- New
- Public Device Record Key
- 3697b769-5559-4e0a-b0a5-95409e8fabb8
Device Description
Large Manual Percussor Cup; 89mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| GWZ | Percussor | Neurology | 882.1700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61027 | Manual chest percussor | A hand-held device designed to facilitate manual percussion (rapid tapping) to provide external vibrations to the chest wall of a patient (neonate to adult) 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 is typically made of soft plastic, in the shape of a cup with a short handle, and available in a range of sizes. This a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10858409005624 | GS1 | 40 | In Commercial Distribution | ||
| Primary | 00858409005627 | GS1 |