FDA UDI
In Commercial Distribution
🇺🇸 United States
Vyaire
DI: 04250892904672
·
Model: V-178500
·
Vyaire Medical GmbH
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vyaire
- Primary DI
- 04250892904672
- Version / Model
- V-178500
- Catalog Number
- V-178500
- Company Name
- Vyaire Medical GmbH
- Labeler DUNS
- 329769991
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-14
- Public Version
- 2
- Public Version Date
- 2021-03-16
- Public Version Status
- Update
- Public Device Record Key
- 2ec08c52-6602-4437-944b-e90bb6c6a5ec
Device Description
Vyntus BODY
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | Anesthesiology | 868.1880 | 2 |
| BTY | Calculator, Predicted Values, Pulmonary Function | Anesthesiology | 868.1890 | 2 |
| JEH | Plethysmograph, Volume | Anesthesiology | 868.1760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35242 | Whole-body plethysmograph | A graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. It includes an airtight body chamber and transducers that allow the recording of chamber pressure versus airflow, and chamber pressure versus mouth pressure, to determine the airway resistance. Thoracic gas volume is typically determined by recording the chamber and airway pressures simultaneously with the airway open and with the airway occluded. It may also be possible to determine the instantaneous flow by recording the pulmonary capillary blood flow with the device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04250892904672 | GS1 |
Customer Contacts
- Phone
- +499314972127
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190853 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius