FDA UDI
In Commercial Distribution
🇺🇸 United States
AVEA™
DI: 10190752156258
·
Model: 16465
·
VYAIRE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AVEA™
- Primary DI
- 10190752156258
- Version / Model
- 16465
- Catalog Number
- 16465
- Company Name
- VYAIRE MEDICAL, INC.
- Labeler DUNS
- 080456871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-29
- Public Version
- 1
- Public Version Date
- 2021-04-06
- Public Version Status
- New
- Public Device Record Key
- 604d3529-8b05-4e28-8681-3da73b2dd247
Device Description
AVEA™ Ventilator HotWire
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
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36849 | Breathing circuit gas-flow sensor, reusable | A device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10190752156258 | GS1 |
Customer Contacts
- Phone
- +1(833)327-3284
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103211 | 000 |