FDA UDI
In Commercial Distribution
🇺🇸 United States
VOCSN Internal Bacterial Filter
DI: 00855573007402
·
Model: 10-Pack
·
VENTEC LIFE SYSTEMS, INC.
Product Codes
4
GMDN Terms
2
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- VOCSN Internal Bacterial Filter
- Primary DI
- 00855573007402
- Version / Model
- 10-Pack
- Catalog Number
- PRT-00976-000
- Company Name
- VENTEC LIFE SYSTEMS, INC.
- Labeler DUNS
- 078758082
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2019-01-30
- Public Version
- 1
- Public Version Date
- 2019-03-04
- Public Version Status
- New
- Public Device Record Key
- 51bc13b9-499e-4c4a-8577-a64ce34a4470
Device Description
VOCSN Internal Bacterial Filter, 10-Pack
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | Anesthesiology | 868.5895 | 2 |
| NOU | Continuous, Ventilator, Home Use | Anesthesiology | 868.5895 | 2 |
| NHJ | Device, Positive Pressure Breathing, Intermittent | Anesthesiology | 868.5905 | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | Anesthesiology | 868.5260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47083 | Portable electric ventilator | A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory). | No | Active |
| 36998 | In-exsufflator | A portable, pneumatic, device that, through a rapid shift in pressure via a face mask, produces a high expiratory flow rate from the lungs, simulating a cough. This technique is referred to as EWNP (exsufflation with negative pressure) or mechanical insufflation-exsufflation. This device is suitable for any patient with an ineffective cough due to, e.g., muscular disorders or paralysis and would typically be used to clear retained broncho-pulmonary secretions, reducing the risk of respiratory complications. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00855573007402 | GS1 | ||||
| Unit of Use | 00855573007525 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162877 | 000 |