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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
—
Phone
+1-269-873-0502
PRRC Contact
Robert Yamashita
EUDAMED SRN
US-MF-000007934
FDA FEI Number
3004748541
DUNS Number
022721133

Catalogue (988)

Page 3 of 20
DeviceModel / ReferenceRegistriesClassStatus
Nasal Cannula (Adult) High Flow, 50’ (15.2 m) 0‐15 LPM supply tube 1600HF-50-10
EUDAMED
Class IIaActive
Nasal Cannula (Pediatric) Salter Style, 7' (2.1 m) 0 to 6 LPM supply tube 16SOFT-PED-7-50
EUDAMED
Class IIaActive
Sampling (no O2) Adult Capnography Cannula, Female Luer Style. 7' Co2 4000F-7-25
EUDAMED
Class IActive
Nasal Cannula (Premature) Salter Style, 7' (2.1 m) supply tube , Thread Grip 1610TG-7-50
EUDAMED
Class IIaActive
Pediatric ETCO2/O2 Nasal Cannula, CO2 female luer style connector 4102F-7-7-25
EUDAMED
Class IIaActive
Pediatric. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector with female thread grip connector. Adaptor 22 mm (ID) x 6 mm (OD). 4703TG-7-7-25
EUDAMED
Class IIaActive
Oxygen Tubing (Green) with 2 standard connectors (6 mm), 25’ (7.6 m) 2025G-25-25
EUDAMED
Class IIaActive
Nasal Cannula (Adult) Salter Style, 7’ (2.1 m) supply tube 1600-7-50
EUDAMED
Class IIaActive
Adult. ETCO2/O2 Nasal Divided Cannula, female luer style CO2 connector. 4950F-7-0-25
EUDAMED
Class IIaActive
Y-Connector with two 7’ bonded green tubes with ribbed fittings 1227-7-7-10
EUDAMED
Class IIaActive
Nasal Cannula (Adult) TLCannula, 1’ (.3 m) supply tube. 1600TLC-1-25
EUDAMED
Class IIaActive
Pediatric. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector. Adaptor 22 mm (I.D.) x 6 mm (O.D.) 4703-7-7-25
EUDAMED
Class IIaActive
Adult ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector and filter. Adaptor 22 mm (I.D.) x 6 mm (O.D.) 4707SP-7-7-25
EUDAMED
Class IIaActive
Nasal Cannula (Adult) High Flow, 50’ (15.2 m) 0‐15 LPM supply tube 1600HF-4-25
EUDAMED
Class IIaActive
Sampling (no O2) Pediatric Capnography Cannula, Female Luer Style. 7' Co2 4100F-7-25
EUDAMED
Class IActive
Adult. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector. Adaptor 22 mm (ID) x 6 mm (OD) 4706F-7-0-25
EUDAMED
Class IIaActive
Adult. O2/ETCO2 Filtered Oral/Nasal Divided Cannula. 4MSF1-7-13-25
EUDAMED
Class IIaActive
Adult. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector. Adaptor 22 mm (ID) x 6 mm (OD). 4707TG-14-14-25
EUDAMED
Class IIaActive
Intermediate Infant. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector. Adaptor (22 mm I.D x 6 mm O.D) 4705F-7-0-25
EUDAMED
Class IIaActive
Nebulizer, Aerosol mask (Pediatric) 8905-0-50
EUDAMED
Class IIbActive
Oxygen Mask (Adult) High concentration non-rebreather, with safety vent, 7’ (2.1 m) supply tube, Elastic strap fixation. 8130-7-50
EUDAMED
Class IIaActive
Nasal Cannula (Infant) Salter Style, 7’ (2.1 m) supply tube 16SOFT-INF-7-50
EUDAMED
Class IIaActive
ComfortCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube ZCC4401HP-10
EUDAMED
Class IActive
Nasal Cannula (Adult) TLCannula, 25’ (7.6 m) supply tube. 1600TLC-25-25
EUDAMED
Class IIaActive
Demand Nasal Cannula (Adult), 7’ (2.1 m) supply tube, dual port demand valve 4907-7-7-25
EUDAMED
Class IIaActive
Adult. Oral-Trac (R) ETCO2/O2 Divided Cannula. Male luer-style CO2 connector, O2 Thread Grip connector. Adapter 22mm (ID) x 6mm (OD). 4797TG-7-7-25
EUDAMED
Class IIaActive
Oxygen Tubing with male and female thread grip connectors, 7’ (2.1 m) 9999-7-50
EUDAMED
Class IIaActive
In-Line Nebulizer Set, T-adaptor (22 mm O.D. x 22 mm O.D. x 18 mm I.D.), reservoir, 7’ (2.1 m) supply tube. 8915-7-50
EUDAMED
Class IIbActive
Nasal Cannula (Adult) Salter Style, 25' (7.6 m) 0 to 6 LPM supply tube 16SOFT-25-25
EUDAMED
Class IIaActive
Oxygen Tubing Swivel Connector. Less than 10 psi 1225-0-25
EUDAMED
Class IIaActive
Oxygen Tubing (Green) with 2 standard connectors (6 mm), 7’ (2.1 m) 2002G-7-50
EUDAMED
Class IIaActive
Nasal Cannula (Adult) Salter Style, 4’ (1.2 m) supply tube 1600-4-50
EUDAMED
Class IIaActive
Pediatric. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector. Adaptor 22 mm (I.D.) x 6 mm (O.D.) 47SOFT-PED-7-0-25
EUDAMED
Class IIaActive
Nasal Cannula (Adult) Salter Style, 25' (7.6 m) 0 to 6 LPM supply tube 16SOFTTG-25-25
EUDAMED
Class IIaActive
Adult. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector. Adaptor 22 mm (ID) x 6 mm (OD). 4707TG-7-7-25
EUDAMED
Class IIaActive
Nasal Cannula (Infant) Salter Style, 7’ (2.1 m) supply tube 1601-7-50
EUDAMED
Class IIaActive
Nasal Cannula (Adult) High Flow, 25’ (7.6 m) 0‐15 LPM supply tube 1600HF-25-10
EUDAMED
Class IIaActive
Nasal Cannula (Adult) Salter Style, no supply tube 16SOFT-0-50
EUDAMED
Class IIaActive
ComfortCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Single Tube ZCC4301HP-10
EUDAMED
Class IActive
Nebulizer, 7’ (2.1 m) supply tube 8902-7-50
EUDAMED
Class IIbActive
ETCO2 Filtered Sampling Line with adult/pediatric 15 mm airway adapter. 4MSF5-13-25
EUDAMED
Class IActive
Oxygen Tubing with 1 standard connector and 1 male thread grip connector, 21" (.53 m). SO-1790
EUDAMED
Class IIaActive
Adult. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector. Adaptor 22 mm (ID) x 6 mm (OD) 4706FTG-7-0-25
EUDAMED
Class IIaActive
Oxygen Mask (Adult), Concentration non-rebreather, with 7’ (2.1 m) supply tube, Elastic Strap fixation. 8140-7-50
EUDAMED
Class IIaActive
NebuTech® 8961-0
FDA UDI
Class IIActive
Parker H-PFOC-50
FDA UDI
Class IIActive
Parker Flex-Tip H-PFRU-50
FDA UDI
Class IIActive
IntuBrite 1020.C2016.C
FDA UDI
Class IActive
Parker H-PFST-65
FDA UDI
Class IIActive
IntuBrite Sterile S01-1023.C.2015.C
FDA UDI
Class IActive

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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.