FDA Registration
Active
🇺🇸 United States
BARBARAS DEVELOPMENT, INC.
Reg #: 3007207474
·
FEI: 3007207474
·
Expires 2026
Products
22
Proprietary Names
15
Establishment Types
3
Classifications
22
Registration Details
- Registration Name
- BARBARAS DEVELOPMENT, INC.
- Registration Number
- 3007207474
- FEI Number
- 3007207474
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2545 W Hillcrest Dr Ste 215
- City
- Thousand Oaks
- State
- CA
- ZIP
- 91320
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251216
Owner / Operator
- Firm Name
- Barbaras Development, Inc.
- Operator Number
- 10026520
- Address
- 2545 W HILLCREST DR STE 215
- City
- Thousand Oaks
- State
- CA
- Postal Code
- 91320
- Country
- US
- Correspondent
- Amy XU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2020-01-10 |
| Components, Exercise | IOD | Class 1 | Physical Medicine | No | 2026-03-03 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2025-06-17 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2019-07-05 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2024-12-12 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2019-01-13 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2019-07-05 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2024-12-12 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2019-01-13 |
| Accessories, Traction | ILZ | Class 1 | Physical Medicine | No | 2019-01-13 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2016-11-25 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2023-03-01 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2026-03-03 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2019-01-13 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2024-12-12 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2023-09-26 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2019-01-13 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2019-07-05 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2014-08-15 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2019-07-05 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2023-10-31 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | NNZ | Class 1 | Gastroenterology, Urology | No | 2019-01-13 |
Proprietary Names
EXERCISER
0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
Procare
DONJOY
Post OP shoe
Stedline PICC Slee
ECONO BREG/OPTIFLEX
POM
Cuffs
CO2 Sampling Line for Non Breaking Oxygen
Powered Moist Steam Pack
Donjoy
DJO
Donjoy, ISOFORM
Non sterile Urine Drainage Bags
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility