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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 20 of 20

Device	Model / Reference	Registries	Class	Status
Mod. 4006 Adu., Oxy. Delive.-Oral Co2 Sam. Cannula	K864903	FDA 510(k)	Class II	Active
Oxygen Cannula Ear Wrap (style A)	K863431	FDA 510(k)	Class I	Active
Modified Oxygen Delivery/Co2 Sample Nasal Cannula	K892406	FDA 510(k)	Class II	Active
Salter Labs Cpap High Flow Cannula System	K040202	FDA 510(k)	Class II	Active
Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)	K961476	FDA 510(k)	Class II	Active
Salter Labs Bubble Humidifier	K161719	FDA 510(k)	Class II	Active
Salter Labs Modified Nebutech Nebulizer	K014056	FDA 510(k)	Class II	Active
Oxygen Conservator	K863657	FDA 510(k)	Class I	Active
Mod. 4003 Adu., Oxy. Delive.-Oral/Nasal Co2 Cannu.	K864902	FDA 510(k)	Class II	Active
Sl01 Oxygen Analyzer	K881473	FDA 510(k)	Class II	Active
Hand Held Pheumatic Powered (disposable) Nebulizer	K870027	FDA 510(k)	Class I	Active
CPAP Cannulaide	K143700	FDA 510(k)	Class II	Active
CapnoVue M1 Mask (Adult), thread grip, 7’ O2 line	4727TG-7-0-50	EUDAMED	Class IIa	Active
Adult Nasal Pressure Monitoring & Gas Sampling Cannula with 7’ (2.1 m) tubes with male/female connector for gas sampling and filter for pressure monitoring	5041-7-7-25	EUDAMED	Class I	Active
Percent-O2-Lock® Assembly	8058-7-50	EUDAMED	Class IIa	Active
Comfort Face Tent (Adult), elastic strap style	1110-0-50	EUDAMED	Class IIb	Active
Adult Nasal Pressure Monitoring Cannula with 7' (2.1 m) tube with filter.	5011-7-25	EUDAMED	Class I	Active
InfuseIT™ 500ml Reusable Pressure Infusor	ZIT-520-5	EUDAMED	Class IIa	Active
I-Guard Aerosol Mask (Adult), elastic strap fixation	8107V-0-50	EUDAMED	Class IIb	Active
InfuseIT™ 1000ml Reusable Pressure Infusor	ZIT-1020-5	EUDAMED	Class IIa	Active
Pediatric Nasal Pressure Monitoring & Gas Sampling Cannula with 7’ (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring	5050-7-7-25	EUDAMED	Class I	Active
InfuseIT™ 3000ml Disposable Pressure Infusor	ZIT-3000-10	EUDAMED	Class IIa	Active
Small Pediatric Nasal Pressure Monitoring & Gas Sampling Cannula with 7’ (2.1 m) tubes with male/female connector for gas sampling and pressure monitoring	5054-7-7-25	EUDAMED	Class I	Active
Oxygen Mask (Pediatric) Medium Concentration, 7’ (2, 1 m) supply tube, elastic strap fixation with Thread Grip	1122TG-7-50	EUDAMED	Class IIa	Active
Adult Oral/Nasal Pressure Monitoring Cannula with 2' (0.6 m) tube with male Luer-lock® connection.	5006-2-25	EUDAMED	Class I	Active
Adult Oral/Nasal Pressure Monitoring Cannula with 7’ (2.1 m) tube with filter.	5005-7-25	EUDAMED	Class I	Active
I-Guard Aerosol Mask (Pediatric), elastic strap fixation	1107-0-50	EUDAMED	Class IIb	Active
Oxygen Mask (Pediatric) Medium Concentration, 7’ (2, 1 m) supply tube, elastic strap fixation with Thread Grip	1122TG-7-50	EUDAMED	Class IIa	Active
Oxygen Mask (Infant) Medium Concentration, 7’ (2.1 m) supply tube, elastic strap fixation	1114-7-50	EUDAMED	Class IIa	Active
Adult Nasal Pressure Monitoring Cannula with 1' (0.3 m) tube with male Luer style connection.	5012-1-25	EUDAMED	Class I	Active
CapnoVue Scope O2/CO2 Mask, reflective connector, 14’ O2 line, 13’ ETCO2 line	47MSF8-14-13-50	EUDAMED	Class IIa	Active
InfuseIT™ 1000ml Disposable Pressure Infusor	ZIT-1000-10	EUDAMED	Class IIa	Active
Pediatric Oxygen Mask High Concentration Non-rebreather, 7’ (2.1m) supply tube, elastic strap fixation.	1140-7-50	EUDAMED	Class IIa	Active
CapnoVue M1 Mask (Adult), thread grip, 14’ O2 line	4727TG-14-0-50	EUDAMED	Class IIa	Active
CapnoVue M1 Mask (Adult), 14’ O2 line	4727-14-0-50	EUDAMED	Class IIa	Active
CapnoVue M1 Mask (Adult), 7’ O2 line	4727-7-0-50	EUDAMED	Class IIa	Active
Adult. O2/ETCO2 Filtered Oral/Nasal Divided Cannula.	4MSF1-0-6-25	EUDAMED	Class IIa	Active
Aerosol Mask (Adult), elastic strap fixation	1100-0-50	EUDAMED	Class IIb	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.