Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681848

FEI Number

3000213164

Entity Name

BLS SYSTEMS, LTD.

City/State/Country

OAKVILLE Ontario, CA

Establishment Address

1124 SOUTH SERVICE RD. WEST, OAKVILLE Ontario L6L 5T7, CA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device

Owner / Operator

BLS SYSTEMS, LTD. (Owner Number: 9027719)

Owner / Operator Contact Address

1124 SOUTH SERVICE RD. WEST, --, Oakville, CA-ON L6L 5T7, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K993194

PMA Number

N/A

All Registered Proprietary Names

Rescuer Rescuer Nebulizer Rescuer MVP Rescuer Guedel Airway Rescuer Rescuer CPR Mask O-Mask Oxygen Mask FLO2MAX Oxygen Mask AMBU RESCUE MASK Rescuer HEPA filter Rescuer BVM Resuscitator Rescuer HEPA Filter BVM Accessory

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2010-12-17
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2021-02-10
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2012-02-13
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2012-02-29
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2010-12-17
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2011-11-14
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	1996-09-03
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2021-02-10
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2011-11-14

Official Correspondent

Stephen Flynn

US Agent Details

Divya Raman Business: Teleflex Inc. Email: divya.raman@teleflex.com Phone: (612) 4231738

Related Public Records

Same Entity

BLS SYSTEMS, LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K945177	Eagle Health Supplies	4-O2 JR. (CPR MOUTH BARRIER)	1994-11-01
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH

Similar Registrations

Registration Number	Establishment Name	Location
9710020	ZHEJIANG ANJI HUABU INDUSTRIAL CO., LTD.	HUZHOU Zhejiang, CN
3007502289	Laboratorios PiSA, S. A. de C.V.	Tlajomulco de Zuniga Jalisco, MX
9611283	DIMEDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
9613910	NARANG MEDICAL, LTD.	New Delhi, IN
3003898360	Teleflex Medical de Tecate, S. de R.L de C.V.	TECATE Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681848. Last updated year: 2026. Please use registration number 9681848 when referencing this establishment in official correspondence.