FDA UDI
In Commercial Distribution
🇺🇸 United States
AEROBIKA OPEP with Manometer
DI: 00762860105041
·
Model: 110504
·
Trudell Medical International
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- AEROBIKA OPEP with Manometer
- Primary DI
- 00762860105041
- Version / Model
- 110504
- Company Name
- Trudell Medical International
- Labeler DUNS
- 203298203
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-18
- Public Version
- 2
- Public Version Date
- 2021-06-22
- Public Version Status
- Update
- Public Device Record Key
- 400ebfe9-5a91-4fbf-b8ea-20bb60a4288b
Device Description
AEROBIKA OPEP with Manometer
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 | 10762860105048 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00762860105041 | GS1 | ||||
| Previous | 62860110504023 | GS1 |
Customer Contacts
- Phone
- 1-519-455-4862
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150173 | 000 |