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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 2 of 20

Device	Model / Reference	Registries	Class	Status
ETCO2 Filtered Sampling Line	4MSF8-6-25	EUDAMED	Class I	Active
Swivel oxygen tubing connector, male-male	1220-0-100	EUDAMED	Class IIa	Active
Nasal Cannula (Pediatric) Salter Style, 4' (1.2 m) 0 to 6 LPM supply tube	16SOFT-PED-4-50	EUDAMED	Class IIa	Active
Nasal Cannula (Adult) TLCannula, no supply tube.	1606TLC-0-25	EUDAMED	Class IIa	Active
Adult. ETCO2/O2 Nasal Divided Cannula, female luer style CO2 connector	49SOFT-F-14-14-25	EUDAMED	Class IIa	Active
Nebulizer, Aerosol mask (Adult), 7’ (2.1 m) supply tube	8924-7-50	EUDAMED	Class IIb	Active
Adult. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector. Adaptor 22 mm (ID) x 6 mm (OD)	4707-13-13-25	EUDAMED	Class IIa	Active
Pediatric. ETCO2/O2 Nasal Divided Cannula, female luer style CO2 connector. Adaptor 22 mm (I.D.) x 6 mm (O.D.)	4703F-7-7-25	EUDAMED	Class IIa	Active
Adult. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector with Thread Grip connector.	49SOFT-TG-10-10-25	EUDAMED	Class IIa	Active
Adult. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector. Adaptor 22 mm (ID) x 6 mm (OD)	4707-10-10-25	EUDAMED	Class IIa	Active
Pediatric. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector. Adaptor 22 mm (I.D.) x 6 mm (O.D.)	47SOFT-PED-7-7-25	EUDAMED	Class IIa	Active
Nasal Cannula (Adult) Salter Style, 14' (4.3 m) 0 to 6 LPM supply tube	16SOFTTG-7-50	EUDAMED	Class IIa	Active
Pediatric. ETCO2/O2 Nasal Divided Cannula, female luer style CO2 connector. Adaptor 22 mm (I.D.) x 6 mm (O.D.)	4702F-7-0-25	EUDAMED	Class IIa	Active
Oxygen Tubing with 2 standard connectors (6 mm), 35’ (10.7 m)	2035-35-20	EUDAMED	Class IIa	Active
Nasal Cannula (Adult) Salter Style, 14' (4.3 m) 0 to 6 LPM supply tube	16SOFT-14-50	EUDAMED	Class IIa	Active
Demand Nasal Cannula (Pediatric), 7’ (2.1 m) supply tube, dual port demand valve	4827-7-7-25	EUDAMED	Class IIa	Active
Nasal Cannula (Intermediate Infant) Salter Style, 7’ (2.1 m) supply tube	1615-7-50	EUDAMED	Class IIa	Active
Nasal Micro Cannula (Adult) Salter Style, 7’ (2.1 m) 0‐3 LPM supply tube	1616-7-50	EUDAMED	Class IIa	Active
Intermediate Infant. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector. Adaptor (22 mm I.D x 6 mm O.D)	4704-7-7-25	EUDAMED	Class IIa	Active
Infant. EtCO/O2 Nasal Divided Cannula, male luer style CO2 connector. Adaptor (22mm I.D x 6 mm O.D)	4701-7-0-25	EUDAMED	Class IIa	Active
Pediatric. O2/ETCO2 Filtered Nasal Divided Cannula.	4MSF3-PED-7-6-25	EUDAMED	Class IIa	Active
Percent-O2-Lock® Mask, (Pediatric) with 7’ (2.1 m) supply tube	8121-7-50	EUDAMED	Class IIa	Active
Adult. ETCO2/O2 Nasal Divided Cannula, female O2 thread grip and female luer style CO2 connector. Adaptor 22 mm (ID) x 6 mm (OD)	4707FTG-7-7-25	EUDAMED	Class IIa	Active
Nasal Cannula (Adult) Salter Style, 50’ (15.2 m) supply tube, female thread grip connector	1699-50-20	EUDAMED	Class IIa	Active
ETCO2 Filtered Sampling Line with adult/pediatric 15 mm airway adapter	4MSF5-L-6-25	EUDAMED	Class I	Active
Adult. ETCO2/O2 Nasal Sampling Cannula, male luer style CO2 connector	4002-7-7-25	EUDAMED	Class IIa	Active
Nasal Cannula (neonate) Salter Style, 7’ (2.1 m) supply tube	1611-7-50	EUDAMED	Class IIa	Active
Adult. ETCO2/O2 Nasal Divided Cannula, female luer style CO2 connector.	4950F-10-10-25	EUDAMED	Class IIa	Active
Adult. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector.	49SOFT-7-7-25	EUDAMED	Class IIa	Active
Nasal (Adult) High Flow TLCannula, 7’ (2.1 m) supply tube	1600HFTLC-7-25	EUDAMED	Class IIa	Active
Nebulizer, I-Guard Mask (Adult), 7’ (2.1 m) supply tube	8927-7-50	EUDAMED	Class IIb	Active
Inline water trap with threaded end cap.	7001-0-25	EUDAMED	Class IIa	Active
Nasal Cannula (Adult) TLCannula, 7’ (2.1 m) supply tube.	1600TLC-7-25	EUDAMED	Class IIa	Active
Oxygen Mask (Adult), High Concentration non-rebreather, without safety vent. with thread grip connector, with 7’ (2.1 m) supply tube	8150TG-7-50	EUDAMED	Class IIa	Active
Nasal Cannula (Adult), 7' (2.1 m), 0 to 6 LPM supply tube	16SOFT-7-50	EUDAMED	Class IIa	Active
Nasal Cannula (Adult) TLCannula, 7’ (2.1 m) supply tube, female thread grip connector	1699TLC-7-25	EUDAMED	Class IIa	Active
Adult. ETCO2/O2 Nasal Divided Cannula, male luer style CO2 connector with Thread Grip connector.	49SOFT-TG-14-14-25	EUDAMED	Class IIa	Active
Adult. O2/ETCO2 Filtered Nasal Divided Cannula.	4MSF3-7-13-100	EUDAMED	Class IIa	Active
High Flow Oxygen Therapy Kit, (1) #1600HFTLC-7 Nasal (Adult) High Flow TLCannula, (1) #7900 Bubble Humidifier (high flow)	7907TLC-7-25	EUDAMED	Class IIa	Active
Nasal Cannula (Infant) Salter Style, 7’ (2.1 m) supply tube	1601TG-7-50	EUDAMED	Class IIa	Active
Adult. ETCO2/O2 Nasal Sampling Cannula, male luer style CO2 connector	4002-14-14-25	EUDAMED	Class IIa	Active
Nebulizer Set, mouthpiece, T-adaptor	8913-0-50	EUDAMED	Class IIb	Active
ComfortCheck Disposable Blood Pressure Cuff Adult Long (26-33cm) - Single Tube	ZCC4221HP-10	EUDAMED	Class I	Active
Adult. ETCO2/O2 Nasal Divided Cannula, female luer style CO2 connector. Adaptor 22 mm (ID) x 6 mm (OD)	4707F-7-7-25	EUDAMED	Class IIa	Active
Percent-O2-Lock® Mask, (Pediatric) with 7’ (2.1 m) supply tube and female thread grip connector.	8121TG-7-50	EUDAMED	Class IIa	Active
Oxygen Mask (Adult) High Concentration non-rebreather, with safety vent. 7’ (2.1 m) supply tube with Thread Grip, Elastic strap fixation	8130TG-7-50	EUDAMED	Class IIa	Active
Bubble Humidifier, 6 PSI safety valve	7600-0-50	EUDAMED	Class IIa	Active
Nasal Cannula (Adult) Salter Style , 14’ (4.3 m) supply tube	1600-14-50	EUDAMED	Class IIa	Active
Adult. ETCO2/O2 Nasal Divided Cannula, female luer style CO2 connector and thread grip connector	4950FTG-7-7-25	EUDAMED	Class IIa	Active
Infant. ETCO2/O2 Nasal Divided Cannula, female luer style CO2 connector. Adaptor (22 mm I.D x 6 mm O.D)	4700F-7-7-25	EUDAMED	Class IIa	Active

Related Companies

Authorised Representatives

Medical Technology Promedt Consulting GmbH DE

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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.

Date	Recall No.	Class	Status	Reason
Jun 25, 2014	Z-2093-2014	—	terminated	The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.
Nov 1, 2013	Z-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, 2012	Z-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, 2011	Z-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, 2011	Z-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.