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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 18 of 20

Device	Model / Reference	Registries	Class	Status
Comfort Soft Plus	0568	FDA UDI	Class I	Active
Parker	H-PFOL-60	FDA UDI	Class II	Active
IntuBrite Sterile	S01-6020.C	FDA UDI	Class I	Active
Parker Flex-Tip	H-PSTDL-28	FDA UDI	Class II	Active
Parker	H-PFUO-65	FDA UDI	Class II	Active
Salter AIRE Elite	SO-1935BK	FDA UDI	Class I	Active
Comfort Soft Plus	0914	FDA UDI	Class II	Active
Salter AIRE Elite, NebuTech	8350-8660	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFOC-40	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFUO-85	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFEC-80	FDA UDI	Class II	Active
Salter AIRE Elite	8350B-8900	FDA UDI	Class I	Active
Parker	H-PFUO-40	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFOC-70	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFOU-45	FDA UDI	Class II	Active
Parker	H-PTCL-55	FDA UDI	Class II	Active
Parker	H-PFLP-100	FDA UDI	Class II	Active
Mini Whiskers	MW100-0-120	EUDAMEDFDA UDI	Class I	Active
Comfort Soft Plus	0921	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFRC-95	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFNC-55	FDA UDI	Class II	Active
IntuBrite Sterile	S01-1032.C.2015.C	FDA UDI	Class I	Active
Salter AIRE Elite	SO-1787BE	FDA UDI	Class II	Active
IntuBrite	1023.C2017.C	FDA UDI	Class I	Active
IntuBrite Sterile	S01-6021.C.6016.C	FDA UDI	Class I	Active
IntuBrite Sterile	S01-1029.C	FDA UDI	Class I	Active
Whisper	OTC-103-4 (QTY 1)	FDA UDI	Class I	Active
Parker	H-PFST-30	FDA UDI	Class II	Active
Parker	H-PFLP-60	FDA UDI	Class II	Active
Parker	H-PTCL-65	FDA UDI	Class II	Active
Parker Flex-Tip	H-PTCY-75	FDA UDI	Class II	Active
Mindray Cannula	SO-2178	FDA UDI	Class II	Active
IntuBrite Sterile	S01-1035.C	FDA UDI	Class I	Active
Parker Flex-Tip	H-PSTDL-32	FDA UDI	Class II	Active
Salter AIRE Elite	SO-1431BE	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFOC-35	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFOU-40	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFNC-90	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFTVPU-75	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFOU-55	FDA UDI	Class II	Active
Grippies	GR102P-0-5	FDA UDI	Class I	Active
Parker Flex-Tip	H-PFST-80	FDA UDI	Class II	Active
Philips MR Patient Care LoFlo Cannula Line	P183281	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFST-45	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFUO-55	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFUO-25	FDA UDI	Class II	Active
Iradimed	1843P	FDA UDI	Class II	Active
Comfort Soft Plus	0507	FDA UDI	Class I	Active
Salter AIRE Elite	SO-1648GN	FDA UDI	Class II	Active
Philips MR Patient Care Sample Line	P183291	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Medical Technology Promedt Consulting GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.