Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010272829

FEI Number

3010272829

Entity Name

Salter Labs de Mexico de S.A. de C.V.

City/State/Country

Chihuahua Mexico, MX

Establishment Address

Blvd. Independencia #2167, Parque Ind. Las Americas - Horizonte Sur. Cd. Juarez, Chihuahua Mexico 32596, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SunMed "also trading as AirLife" (Owner Number: 9038422)

Owner / Operator Contact Address

2710 Northridge Drive NW, Suite A, Grand Rapids, MI 49544, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K772127

PMA Number

N/A

All Registered Proprietary Names

Airflow resuscitator Capnovue Salter Labs® 8900 Series Small Volume Jet Nebulizer DuraCheck Blood Pressure Cuff ResMed Apnealink Sensor O2 express Liter Meter Salter Labs Nebulizer exhalation filter, 8680 series Salter Style Cannula Salter NebuTech® HDN®Reusable Nebulizer Salter Labs Demand Cannulas ACCU-FLOW Venturi Oxygen System Comfort Soft Plus Cannula Cannula, Nasal, Oxygen, with E-Z wraps VitalCheck Blood Pressure Cuff CO2 Comfort Soft Plus Cannula Salter Labs Peak Flow Meter Salter Labs In Line Water Trap Tilson Trach Guard and Tether Salter Labs nasal cannulas, 16Soft series, 16 series, high flow series, OTC series, gator and ear wraps accessory Comfort Soft Plus CPAP Cannulaide® O2 Boot O2 Sacral Humidifier PneumoTherm ThermiSense Salter Labs Oxygen Mask - Non-rebreathing Mini Heart Nebulizer (Westmed) Grippies, Silicon Strips, MiniWhiskers, StickyWhiskers Sensitive Grips, Tender Grips Salter Labs PEP Device Nebulizer PRO2 PRO2-Elite Luma Wrap Salter Labs Sleep Diagnostic Cannulas, non DEHP ResMed Salter Labs Bubble Humidifier Oxygen tubing, connectors, and accessories Salter Aire Elite Compressor (Apex Minitab) Salter Labs Nebulizer exhalation filter, 8980 series Salter NebuTech® HDN® Disposable Nebulizer IntuBrite Laryngoscope Salter Labs Humidifier 7900 Series; 7900 Series with Cannula Kit Salter Labs Infant Face Mask Salter Labs® Percent-O2-Lock® Venturi System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2020-01-03
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2018-11-20
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2018-11-20
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2009-01-12
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2015-06-18
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2024-06-26
NFB	Conserver, Oxygen	Anesthesiology	Class 2	868.5905	2008-03-25
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	2014-07-09
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2009-09-09
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2009-09-09
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2009-01-12
NFB	Conserver, Oxygen	Anesthesiology	Class 2	868.5905	2016-06-22
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	1992-12-21
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2022-01-28
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2009-09-09
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2015-10-06
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2022-01-28
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2022-01-28
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2013-11-21
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2009-03-03
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2012-01-04
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	1992-12-21
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2015-08-10
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	Class 2	878.5650	2021-02-19
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2026-05-19
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2010-09-15
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2008-10-16
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	1992-12-21
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2024-05-21
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2014-11-04
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2009-03-05
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2009-09-09
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2008-10-16
PDH	Blanket, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2015-06-22
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2016-06-22
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2016-06-22
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2019-02-19
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2007-04-10
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2014-08-05
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2009-02-05
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2009-09-09
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2009-01-12
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2017-07-14
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2012-02-17
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2009-09-09
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2009-03-04

Official Correspondent

Rob Yamashita

US Agent Details

Rob Yamashita Business: AirLife Email: ryamashita@myairlife.com Phone: (616) 2598373

Related Public Records

Same Entity

SunMed "also trading as AirLife"

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004748541	Salter Labs	El Paso, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.
Z-0042-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s 5808, 12-8704; 724-E; 724MM, 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products.
Z-0043-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distributiuon only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada.

Similar Registrations

Registration Number	Establishment Name	Location
3014507910	FC COMPANY LTD	Hong kong, HK
3005587132	Westmed Javid de Mexico, S.A. de C.V.	NOGALES Sonora, MX
9710391	POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD.	XIAMEN Fujian, CN
3010402691	FOREMOUNT ENTERPRISE CO., LTD.	Taichung City, TW
1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010272829. Last updated year: 2026. Please use registration number 3010272829 when referencing this establishment in official correspondence.