FDA Registration
Active
🇹🇷 Türkiye
HIGH CONCENTRATION OXYGEN MASK (PEDIATRIC) - 130 111
Reg #: 3018762668
·
FEI: 3018762668
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- PLASTI-MED PLASTIK MEDIKAL URUNLER SAN. VE TIC. LTD. STI.
- Registration Number
- 3018762668
- FEI Number
- 3018762668
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Deri Osb Mahallesi Yan Sanayi Cad. No:13
- City
- Tuzla Istanbul
- Country
- TR
Owner / Operator
- Firm Name
- Plasti-med Plastik Medikal Urunler San. ve Tic. Ltd. Sti.
- Operator Number
- 10080023
- Address
- Deri Osb Mahallesi Yan Sanayi Cad. No:13
- City
- Tuzla
- State
- Istanbul
- Postal Code
- 34956
- Country
- TR
- Correspondent
- Cemile Hande TUNC
US Agent
- Business Name
- Healthcare International Partners Llc
- Contact Name
- Margarita Morales
- Address
- 2750 Sw 145th Ave Ste 101
- City
- Miramar
- State
- FL
- ZIP
- 33027
- Country
- US
- [email protected]
- Phone
- 786 3602695 ext. 104
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2021-03-23 |
Proprietary Names
HIGH CONCENTRATION OXYGEN MASK (PEDIATRIC) - 130 111
DISPOSABLE AIR CUSHION MASK NO:0 NEONATAL - 130 210
DISPOSABLE AIR CUSHION MASK NO:4 SMALL ADULT - 130 214
DISPOSABLE AIR CUSHION MASK NO:5 ADULT - 130 215
DISPOSABLE AIR CUSHION MASK NO:3 CHILD - 130 213
SILICON MASK NO:5 ADULT - 130 225
HIGH CONCENTRATION OXYGEN MASK -ADULT (NEW TYPE) - 130 060
SILICON MASK NO:1 INFANT - 130 221
HIGH CONCENTRATION OXYGEN MASK (ADULT) - 130 110
OXYGEN MASK PEDIATRIC - 130 104
SILICON MASK NO:4 SMALL ADULT - 130 224
SILICON MASK NO:2 PEDIATRIC - 130 222
DISPOSABLE AIR CUSHION MASK NO:2 PEDIATRIC - 130 212
SILICON MASK NO:0 NEONATAL - 130 220
OXYGEN MASK/ADULT (NEW TYPE) - 130 053
OXYGEN MASK INFANT - 130 059
DISPOSABLE AIR CUSHION MASK NO:1 INFANT - 130 211
SILICON MASK NO:3 CHILD - 130 223
OXYGEN MASK ADULT - 130 103
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device