FDA Registration
Active
🇺🇸 United States
Planet Innovation Products, Inc.
Reg #: 2022994
·
FEI: 2022994
·
Expires 2026
Products
7
Proprietary Names
7
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Planet Innovation Products, Inc.
- Registration Number
- 2022994
- FEI Number
- 2022994
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 80 Technology Drive
- City
- IRVINE
- State
- CA
- ZIP
- 92618
- Country
- US
Owner / Operator
- Firm Name
- Planet Innovation Products, Inc.
- Operator Number
- 9063957
- Address
- 80 Technology Drive, --
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2012-12-26 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2023-11-27 |
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | Class 1 | Microbiology | No | 2023-11-27 |
| Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection | QDZ | Class 2 | Microbiology | No | 2021-06-17 |
| System, Test, Radioallergosorbent (Rast) Immunological | DHB | Class 2 | Immunology | No | 2012-12-26 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2021-06-17 |
| C. Difficile Nucleic Acid Amplification Test Assay | OMN | Class 1 | Microbiology | No | 2012-12-26 |
Proprietary Names
KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
Sofia2
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)