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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 14 of 20

Device	Model / Reference	Registries	Class	Status
Parker	H-PFOC-85	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFOC-60	FDA UDI	Class II	Active
ThermiSense	5755-7-7	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFHV-45	FDA UDI	Class II	Active
IntuBrite Sterile	S01-6033.C.6016.C	FDA UDI	Class I	Active
Parker	H-PSTDL-35	FDA UDI	Class II	Active
Philips MR Patient Care Sample Line	P183251	FDA UDI	Class II	Active
Whisper	OTC-103-7 (QTY 1)	FDA UDI	Class I	Active
Vital Signs™	5630I	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFOL-30	FDA UDI	Class II	Active
Iradimed	1844P	FDA UDI	Class II	Active
Parker Flex-Tip	H-PTCL-35	FDA UDI	Class II	Active
BiNAPS	5530-0	FDA UDI	Class II	Active
Parker	H-PFRU-45	FDA UDI	Class II	Active
NeoCheck	ZNCC4901HP-10	FDA UDI	Class II	Active
Comfort Soft Plus	0916	FDA UDI	Class II	Active
Salter Labs	47SOFT-TG-14-14-25	FDA UDI	Class II	Active
ThermiSense	5700S20-0	FDA UDI	Class II	Active
IntuBrite Sterile	S01-1033.C	FDA UDI	Class I	Active
Silhouette	OTC-104-4 (QTY 1)	FDA UDI	Class I	Active
Parker Flex-Tip	H-PFRU-35	FDA UDI	Class II	Active
CapnuVue	4745-7-7	FDA UDI	Class II	Active
ThermiSense	5744-7-7	FDA UDI	Class II	Active
ThermiSense	5700PEK-2-0	FDA UDI	Class II	Active
IntuBrite Sterile	S01-6039.C.61016.C	FDA UDI	Class I	Active
InfuseIT	ZIT-1000	FDA UDI	Class I	Active
Parker Flex-Tip	H-PFLP-55	FDA UDI	Class II	Active
Parker Flex-Tip	H-PSTDL-35	FDA UDI	Class II	Active
Comfort Soft Plus	0556-EM	FDA UDI	Class I	Active
IntuBrite	2017.C	FDA UDI	Class I	Active
Comfort Soft Plus	0167	FDA UDI	Class I	Active
Parker Flex-Tip	H-PFOU-90	FDA UDI	Class II	Active
Parker Flex-Tip	H-PTCL-70	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFTVPU-70	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFRC-90	FDA UDI	Class II	Active
CO2 Sampling Nasal Cannula	0501	FDA UDI	Class I	Active
IntuBrite	1031.C2016.C	FDA UDI	Class I	Active
Salter AIRE Elite	SO-1811BK	FDA UDI	Class II	Active
Parker	H-PFHV-55	FDA UDI	Class II	Active
IntuBrite Sterile	S01-6030.C.6016.C	FDA UDI	Class I	Active
IntuBrite Sterile	S01-1031.C2016.C	FDA UDI	Class I	Active
Parker	H-PFOC-45	FDA UDI	Class II	Active
Philips MR Patient Care LoFlo Cannula Line	P183271	FDA UDI	Class II	Active
IntuBrite	1029.C	FDA UDI	Class I	Active
Parker Flex-Tip	H-PFHV-30	FDA UDI	Class II	Active
Parker	H-PFST-60	FDA UDI	Class II	Active
Salter Labs	SO-1975	FDA UDI	Class I	Active
Comfort Soft Plus	0912	FDA UDI	Class II	Active
Parker	H-PMLT-40	FDA UDI	Class II	Active
IntuBrite	6032.C	FDA UDI	Class I	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.