FDA Registration
Active
🇺🇸 United States
KENTEC MEDICAL, INC.
Reg #: 2080225
·
FEI: 2080225
·
Expires 2026
Products
12
Proprietary Names
15
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- KENTEC MEDICAL, INC.
- Registration Number
- 2080225
- FEI Number
- 2080225
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 17871 FITCH
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
Regulatory Submissions
- 510(k) Number
- K050443
Owner / Operator
- Firm Name
- KENTEC MEDICAL, INC.
- Operator Number
- 2080225
- Address
- 17871 FITCH, --
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2006-02-07 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2006-02-07 |
| Supplies, Blood-Bank | KSS | Class 1 | Hematology | No | 2014-10-22 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2012-05-16 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2020-06-01 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2020-07-28 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2020-07-28 |
| Tube, Feeding | FPD | Class 2 | Gastroenterology, Urology | No | 2020-07-28 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2024-06-18 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2006-02-07 |
| Utensil, Eating | ILC | Class 1 | Physical Medicine | No | 2013-12-31 |
| Enteral Syringes With Enteral Specific Connectors | PNR | Class 2 | Gastroenterology, Urology | No | 2016-10-05 |
Proprietary Names
HAVE A HEART ELECTRODE
Accutemp(r)
PROBE COVER
RadTag Gamma indicator
Hummi Micro Draw
Ameritus Oral Syringe(GB), Ameritus push-in Bottle Adapter(GB)
Ameritus ENFit enteral feeding tube(vr)
Swab-eze
Ameritus Entral(tm) Feeding Tube
Ameritus Enteral Extension Set
ACCU-BOARD
Ameritus(R) Milk Straw
Ameritus ENFit(r) Enteral Syringes
RadTag x-ray indicator
Ameritus(tm) Enteral/Oral Syringe
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198