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SALTER LABS

United States·US-MF-000007934

Last updated September 17, 2026

Information

Country
United States
Address
30, Spur Drive, El Paso, United States
Website
myairlife.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1-269-873-0502
PRRC Contact
Robert Yamashita
EUDAMED SRN
US-MF-000007934
FDA FEI Number
3004748541
DUNS Number
022721133

Catalogue (988)

Page 19 of 20
DeviceModel / ReferenceRegistriesClassStatus
Salter AIRE Elite SO-1921BE
FDA UDI
Class IIActive
Parker H-PFHV-60
FDA UDI
Class IIActive
Parker H-PFHV-35
FDA UDI
Class IIActive
Salter AIRE Elite, NebuTech 8352-8660-7-1
FDA UDI
Class IIActive
Parker H-PFLP-40
FDA UDI
Class IIActive
Parker H-PFNU-45
FDA UDI
Class IIActive
Parker Flex-Tip H-PFHV-50
FDA UDI
Class IIActive
IntuBrite Sterile S01-6022.C.6015.C
FDA UDI
Class IActive
IntuBrite Sterile S01-6035.C
FDA UDI
Class IActive
IntuBrite Sterile S01-1020.C
FDA UDI
Class IActive
Parker Flex-Tip H-PFTVVC-75
FDA UDI
Class IIActive
CapnoVue M1 Mask (Infant), 7’ O2 line 4723-7-0-50
EUDAMED
Class IIaActive
Pediatric Nasal Pressure Monitoring Cannula with 7' (2.1 m) tube with male luer style connection 5022-7-25
EUDAMED
Class IActive
InfuseIT™ 500ml Disposable Pressure Infusor ZIT-500-10
EUDAMED
Class IIaActive
BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal K151874
FDA 510(k)
Class IIActive
Oxygen Analyzer 200 K840361
FDA 510(k)
Class IIActive
Models 4002/4102/4202 Oxy. Delivery/Co2 Cannula K863883
FDA 510(k)
Class IIActive
Oxygen/Temperature Analyzer Model 300 Series K881663
FDA 510(k)
Class IIActive
Oxygen Mask, Air-Entrainment K772127
FDA 510(k)
Class IActive
Oxygen Cannula Ear Wrap (style B) K863432
FDA 510(k)
Class IActive
Salter Labs 8990 Series Nebulizer K962085
FDA 510(k)
Class IIActive
Hand Held Nebulizer System K884947
FDA 510(k)
Class IIActive
Pneumatic Demand Oxygen Conserver (pdoc) K990678
FDA 510(k)
Class IIActive
Salter Labs Infant Nasal Cpap Cannula K912434
FDA 510(k)
Class IIActive
Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff K190878
FDA 510(k)
Class IIActive
Salter Labs #4001 Oral Nasal Co2 Sampling Cannula K864199
FDA 510(k)
Class IIActive
Salter Labs Disposable Nipple And Nut K912174
FDA 510(k)
Class IActive
Salter Labs #4004/4104 Oxygen Mask W/C02 Samp Line K865047
FDA 510(k)
Class IActive
Salter Labs Neonatal Nasal Oxygen Cannula K911740
FDA 510(k)
Class IActive
Sl02 Oxygen Analyzer K881472
FDA 510(k)
Class IIActive
Salter Voluchek 6600 K863656
FDA 510(k)
Class IIActive
Salter Labs 3000 Series Percussors K863658
FDA 510(k)
Class IIActive
Salter Labs Single Patient Use Exhalation Aerosol Filter K992986
FDA 510(k)
Class IIActive
Salter Labs Model #4005 Gas Sampling Tee And Line K865046
FDA 510(k)
Class IActive
Pneumotherml, Model: 5800 K092685
FDA 510(k)
Class IIActive
Salter Labs Pep Device K991788
FDA 510(k)
Class IIActive
Challenger Dosimeter K870755
FDA 510(k)
Class IActive
Luma Wrap K142416
FDA 510(k)
Class IIActive
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula K151506
FDA 510(k)
Class IIActive
Salterlabs 8660 Series Nebulizer K962879
FDA 510(k)
Class IIActive
Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines K151421
FDA 510(k)
Class IIActive
Modified Demand Nasal Oxygen Cannula K892407
FDA 510(k)
Class IIActive
Salter Labs Model #1015 K903539
FDA 510(k)
Class IActive
Salter Labs Nebulizer Exhalation Aerosol Filter K983403
EUDAMEDFDA 510(k)FDA UDI
Class IIActive
Salter Labs Model 4000 Nasal Co2 Sample Line K863703
FDA 510(k)
Class IIActive
Salter Labs Model #4009 Sample Lines K894350
FDA 510(k)
Class IIActive
Bi-Naps Nasal Airflow And Snore Transducer K051313
FDA 510(k)
Class IIActive
Demand Nasal Oxygen Cannula Models 4008/4108/4208 K890298
FDA 510(k)
Class IIActive
Flow Interruption Indicator K863659
FDA 510(k)
Class IActive
Salter Aire Compressor K992285
FDA 510(k)
Class IIActive

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Jun 25, 2014Z-2093-2014—terminated

The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.

Nov 1, 2013Z-0360-2014—terminated

It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male Luer lock connectors may contain a 30' tube instead of the 15' length.

May 30, 2012Z-1898-2012—terminated

A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock connector actually contained product with a female luer lock connector.

Dec 7, 2011Z-0605-2012—terminated

Mis-labeling: report of cases labeled as 4707 (cannulas with male luer lock connector) actually contained 4707F (with female luer lock connectors).

Oct 21, 2011Z-0803-2012—terminated

A manufacturing defect was discovered internally which indicates that in a small number of humidifier lids, the pop-off may not occur at the appropriate pressure and can result in a leak.