FDA Registration
Active
🇲🇽 Mexico
Cannula, Nasal, Oxygen, with E-Z wraps
Reg #: 3010272829
·
FEI: 3010272829
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Salter Labs de Mexico de S.A. de C.V.
- Registration Number
- 3010272829
- FEI Number
- 3010272829
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Blvd. Independencia #2167, Parque Ind. Las Americas - Horizonte Sur. Cd. Juarez
- City
- Chihuahua Mexico
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K863432
Owner / Operator
- Firm Name
- SunMed
- Operator Number
- 9038422
- Address
- 2710 Northridge Drive NW, Suite A
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49544
- Country
- US
- Correspondent
- Rob Yamashita
US Agent
- Business Name
- SunMed Group Holdings, LLC dba AirLife
- Contact Name
- Rob Yamashita
- Address
- 2710 Northridge Dr NW, STE A
- City
- Grand Rapids
- State
- MI
- ZIP
- 49544
- Country
- US
- [email protected]
- Phone
- 616 2598373
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2009-09-09 |
Proprietary Names
Cannula, Nasal, Oxygen, with E-Z wraps
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device