FDA Registration
Active
🇨🇦 Canada
BLS SYSTEMS, LTD.
Reg #: 9681848
·
FEI: 3000213164
·
Expires 2026
Products
12
Proprietary Names
15
Establishment Types
5
Classifications
12
Registration Details
- Registration Name
- BLS SYSTEMS, LTD.
- Registration Number
- 9681848
- FEI Number
- 3000213164
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1124 SOUTH SERVICE RD. WEST
- City
- OAKVILLE Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K051260
Owner / Operator
- Firm Name
- BLS SYSTEMS, LTD.
- Operator Number
- 9027719
- Address
- 1124 SOUTH SERVICE RD. WEST, --
- City
- Oakville
- State
- Ontario
- Postal Code
- L6L 5T7
- Country
- CA
- Correspondent
- Stephen - Flynn
US Agent
- Business Name
- Teleflex Inc.
- Contact Name
- Divya Raman
- Address
- 3015 Carrington Mill Boulevard
- City
- Morrisville
- State
- NC
- ZIP
- 27560
- Country
- US
- [email protected]
- Phone
- 612 4231738
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2010-12-17 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2021-02-10 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2012-02-13 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2012-02-29 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2010-12-17 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2011-11-14 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 1996-09-03 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2021-02-10 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2011-11-14 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2025-01-30 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2013-08-12 |
| Airway Suction Kit | OFO | Class 1 | Anesthesiology | No | 2012-02-14 |
Proprietary Names
Rescuer
Rescuer Nebulizer
Rescuer MVP
Rescuer Guedel Airway
Rescuer CPR Mask
O-Mask Oxygen Mask
FLO2MAX Oxygen Mask
AMBU RESCUE MASK
Rescuer HEPA filter
Rescuer BVM Resuscitator
Rescuer HEPA Filter BVM Accessory
SOBIstat
SOBIstat-F
Rescuer Emergency CPAP
Rescuer Emergency CPAP System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Foreign Private Label Distributor