FDA UDI
In Commercial Distribution
🇺🇸 United States
Inogen Tidal Assist Ventilator Controller
DI: 00817131020216
·
Model: VC-100
·
INOGEN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Inogen Tidal Assist Ventilator Controller
- Primary DI
- 00817131020216
- Version / Model
- VC-100
- Catalog Number
- VC-100
- Company Name
- INOGEN, INC.
- Labeler DUNS
- 136729634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-13
- Public Version
- 1
- Public Version Date
- 2020-03-23
- Public Version Status
- New
- Public Device Record Key
- 1d79ae28-b482-4fbb-965c-7a55c23876a6
Device Description
Inogen Tidal Assist Ventilator Controller
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| ONZ | Mechanical Ventilator | Anesthesiology | 868.5895 | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817131020216 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152664 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity