FDA Registration
Active
🇺🇸 United States
Defibrillation Electrodes
Reg #: 3027815
·
FEI: 1000127185
·
Expires 2025
Products
1
Proprietary Names
26
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TZ MEDICAL, INC.
- Registration Number
- 3027815
- FEI Number
- 1000127185
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 20497 Sw Teton Ave
- City
- Tualatin
- State
- OR
- ZIP
- 97062
- Country
- US
Regulatory Submissions
- PMA Number
- P200005
Owner / Operator
- Firm Name
- TZ MEDICAL, INC.
- Operator Number
- 9006202
- Address
- 20497 SW Teton Avenue, Suite A, --
- City
- Tualatin
- State
- OR
- Postal Code
- 97062
- Country
- US
- Correspondent
- John - Lubisich
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2024-06-11 |
Proprietary Names
Defibrillation Electrodes
P-111-T1
Multi-Function Defibrillator Electrodes Adult - Sterile
P-212-M1, Medtronic
P-311-Z1, Zoll
P-122-Z1 , Zoll, Sterile
P-214-T1
P-311-T1
P-224-T1, Sterile
P-224-Z1, Zoll, Sterile
P-121-T1, Sterile
Multi-Function Defibrillator Electrodes Pediatric - Sterile
P-211-Z1, Zoll
P-311-M1, Medtronic
P-211-M1, Medtronic
Multi-Function Defibrillator Electrodes Adult
P-122-T1, Sterile
P-214-Z1, Zoll
P-111-Z1, Zoll
Multi-Function Defibrillator Electrodes Pediatric
P-212-Z1, Zoll
P-214-M1, Medtronic
P-111-M1, Medtronic
P-121-Z1, Zoll, Sterile
P-112-T1
P-211-T1
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility