FDA UDI
In Commercial Distribution
🇺🇸 United States
Curaplex
DI: 00818834020343
·
Model: 301-44F10-120
·
TRI-ANIM HEALTH SERVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Curaplex
- Primary DI
- 00818834020343
- Version / Model
- 301-44F10-120
- Catalog Number
- 301-44F10-120
- Company Name
- TRI-ANIM HEALTH SERVICES, INC.
- Labeler DUNS
- 010712461
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-18
- Public Version
- 4
- Public Version Date
- 2021-06-22
- Public Version Status
- Update
- Public Device Record Key
- ef71f478-5b66-429a-9ee0-ef523c4100fc
Device Description
Oscillatory PEP Therapy System, VibraPEP, No Tee
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| BWF | SPIROMETER, THERAPEUTIC (INCENTIVE) | Anesthesiology | 868.5690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43947 | Positive pressure airway secretion-clearing device | A hand-held, non-powered device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airways using positive pressure airway (PEP) to treat patients affected by acute or chronic lung disease. PEP is created when a patient exhales into the device which creates vibrations in the chest by various means (e.g., an oscillating ball or creating bubbles in a solution within the device) loosening the mucus for expectoration and assisting in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00818834020367 | GS1 | BX | 10 | In Commercial Distribution | |
| Primary | 00818834020343 | GS1 | ||||
| Package | 00818834020381 | GS1 | CS | 120 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K153441 | 000 |