Salter Labs

FDA Device Registration & Listing · El Paso, TX, US · Registration 3004748541

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004748541
FEI Number
3004748541
Entity Name
Salter Labs
City/State/Country
El Paso, TX, US
Establishment Address
30 Spur Drive, El Paso, TX 79906, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
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
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

STIMULATOR, NERVE, BATTERY-POWERED IntuBrite Laryngoscope Salter Aire Elite Compressor (Apex Minitab) CO2 Comfort Soft Plus Cannula Utopia AV Double Lumen endobroncheal Tube, Parker Parker Standard Tip Endobronchial Tube Salter Labs Oxygen Mask - Non-rebreathing Salter Labs Elongated Style Adult and Pediatric Style Mask TwinMed -Mask Partial Non-Rebreather Westmed Masks Trach-Vac Endotracheal Tube with Flex Tip/PVC cuff & Stylet (PFTVVCS) Salter Labs Trach-Vac Endotracheal Tube Trach-Vac Endotracheal Tube with Flex Tip (PFTVPUS) Trach-Vac Endotracheal Tube with Flex Tip/PVC cuff (PFTVVC) Salter Labs EtCO2 sampling cannulas and gas sampling lines, non-DEHP SalterStat Capnography Product Line Salter Labs Infant Face Mask Salter Spirometer Salter Labs Humidifier 7900 Series; 7900 Series with Cannula Kit Salter Labs Peak Flow Meter PneumoTherm Salter Labs In Line Water Trap Disposable blood pressure cuff Parker Intubating Stylet, sheathed (STLT) Parker Flex-it Directional Stylet Gas Sampling Lines Kit and Gas Tubing Salter AIRE Plus® Salter NebuTech® HDN® Disposable Nebulizer Pressure Infusor Infusor, Disposable, INFUSEIT Infusor, Reusable, INFUSEIT Salter Labs nasal cannulas, 16Soft series, 16 series, high flow series, OTC series, gator and ear wraps accessory Comfort Soft Plus Salter Labs® 8900 Series Small Volume Jet Nebulizer Aspen Hybrid Sensitive Grips, Tender Grips Salter Labs Sleep Diagnostic Cannulas, non DEHP ResMed Salter Style Cannula THERAPEP DHD Healthcare Corp Aloha Nasal Aire II Bravo Luma Wrap Nasal Aire Salter Labs PEP Device Nebulizer Endotracheal Tube Curved, w/ stylet (PFRUS) Endotrachael Tube, Preformed Nasal, cuffed (PFNC) Endotrachael Tube, Preformed Nasal, uncuffed (PFNU) Parker Standard Tip Endobronchial Tube (PSTDR) Endotracheal Tube, Polyurethane, ThinCuff (PTCL) EasyCurve Endotracheal Tube, Cuffed (PFEC) Endotrachael Tube, High Volume, Low pressure, cuffed (PFST) with stylet Endotracheal Tube, Preformed, Nasal, Cuffed (PFNC) Endotracheal Tube, Reinforced, Cuffed (PFRC) Endotracheal Tube, Reinforced, uncuffed (PFRU) Endotracheal Tube, Polyurethane, ThinCuff (PTCY) Endotrachael Tube, High Volume, Low pressure, cuffed (PFHV) Micro-laryngeal Tube, Parker flex tip (PMLT) Endotracheal Tube, High Volume, Low Pressure, cuffed with Stylet (PFST) Parker Standard Tip Endobronchial Tube (PSTDL) Endotracheal Tube, Preformed Oral Cuffed Low Profile (PFOL) Parker Flex Tip Tracheal Tube, uncuffed (PFUO) Endotrachael Tube, Preformed Oral, uffed (PFOC) Endotrachael Tube, Preformed Oral, Uncuffed (PFOU) Endotrachael Tube, Low pressure, cuffed (PFLP) ENDOTRACHEAL TUBE, REINFORCED, CURVED, UN-CUFFED (PFRO) Endotracheal Tube, Reinforced, Cuffed w/ stylet (PFRCS) Endotracheal Tube, Reinforced, Cuffed (PFRP) Salter NebuTech® HDN®Reusable Nebulizer Salter Labs® Percent-O2-Lock® Venturi System Salter Labs Nebulizer exhalation filter, 8680 series Hybrid AV Grippies, Silicon Strips, MiniWhiskers, StickyWhiskers Salter Labs Bubble Humidifier Liter Meter Parker Laryngeal Mask, Disposable, Wire Reinforced Parker Laryngeal Mask, disposable, silicone

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BXN Stimulator, Nerve, Battery-Powered Anesthesiology Class 2 868.2775 2025-07-23
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2017-07-14
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 2022-01-28
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2022-01-28
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2017-07-28
CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) Anesthesiology Class 2 868.5740 2017-09-23
KGB Mask, Oxygen, Non-Rebreathing Anesthesiology Class 1 868.5570 1992-12-21
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 1992-12-21
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2020-01-15
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2016-05-03
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2009-09-09
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2009-09-09
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2012-02-17
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2013-11-21
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2010-09-15
BYH Drain, Tee (Water Trap) Anesthesiology Class 1 868.5995 2009-03-03
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2015-06-18
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2015-06-22
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2015-06-18
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2009-01-12
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2009-01-12
KZD Infusor, Pressure, For I.V. Bags General Hospital Class 1 880.5420 2015-06-18
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 1992-12-21
CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer) Anesthesiology Class 1 868.5640 2009-01-12
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2017-07-28
CBH Device, Fixation, Tracheal Tube Anesthesiology Class 1 868.5770 2009-03-05
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2016-06-22
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2016-06-22
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2009-09-09
BWF Spirometer, Therapeutic (Incentive) Anesthesiology Class 2 868.5690 2014-07-11
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2017-07-28
PDH Blanket, Neonatal Phototherapy General Hospital Class 2 880.5700 2015-06-22
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2017-07-28
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2009-09-09
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2017-09-23
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2009-01-12
BYF Mask, Oxygen, Low Concentration, Venturi Anesthesiology Class 1 868.5600 2009-03-04
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2009-09-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2017-07-28
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2014-11-04
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2019-02-19
BXY Flowmeter, Calibration, Gas Anesthesiology Class 1 868.2350 2014-07-09
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2017-09-23

Official Correspondent

Rob Yamashita

US Agent Details

No US Agent registered (Local establishment).

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
3010272829 Salter Labs de Mexico de S.A. de C.V. Chihuahua Mexico, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K860126 Burron Medical Products, Inc. STIMUPLEX, NERVE STIMULATOR 1986-02-28
K163485 Adherium (Nz), Ltd. SmartTouch 2017-08-30
K781467 Travenol Laboratories, S.A. U-FLOAT VALVE 2D9023 1978-09-07
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0144-2024 Covidien 1
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004748541. Last updated year: 2026. Please use registration number 3004748541 when referencing this establishment in official correspondence.
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