FDA Registration
Active
🇺🇸 United States
D R BURTON HEALTHCARE, LLC
Reg #: 3012970776
·
FEI: 3012970776
·
Expires 2026
Products
7
Proprietary Names
10
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- D R BURTON HEALTHCARE, LLC
- Registration Number
- 3012970776
- FEI Number
- 3012970776
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3936 S FIELDS ST
- City
- Farmville
- State
- NC
- ZIP
- 27828
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192000
Owner / Operator
- Firm Name
- D R Burton Healthcare LLC
- Operator Number
- 10052794
- Address
- 3936 South Fields Street, PO Box 433
- City
- Farmville
- State
- NC
- Postal Code
- 27828
- Country
- US
- Correspondent
- Joyce Burton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2018-10-24 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2020-02-21 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2020-02-21 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2018-10-24 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2018-10-24 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2019-07-17 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2020-02-24 |
Proprietary Names
J-Wand
OxyPAP
T-Piece adaptor
Nut & Nipple Adapter
OxyJet
OxyTrainer
OxyTrainer Advantage
iPEP system
PocketPEP
vPEP
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device