FDA UDI
In Commercial Distribution
🇺🇸 United States
3100A HFOV
DI: 50190752159769
·
Model: 29028-007
·
VYAIRE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3100A HFOV
- Primary DI
- 50190752159769
- Version / Model
- 29028-007
- Catalog Number
- 29028-007
- Company Name
- VYAIRE MEDICAL, INC.
- Labeler DUNS
- 080456871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-05
- Public Version
- 2
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- b751ca5c-9422-42dd-9405-62c05bbc96e2
Device Description
Flexible Patient Circuit, 3100A 380-88/ 400-00 in Non-Heated Environment (Box of 4)
Device Characteristics
- Single Use
- Yes
- 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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LSZ | VENTILATOR, HIGH FREQUENCY | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37706 | Ventilator breathing circuit, single-use | An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 50190752159769 | GS1 |
Customer Contacts
- Phone
- +1(833)327-3284
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P890057 | 000 |