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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 8 of 20

Device	Model / Reference	Registries	Class	Status
Salter AIRE Elite	SO-1005GN	FDA UDI	Class I	Active
Parker	H-PFOC-60	FDA UDI	Class II	Active
CapnuVue	4727-14-0	FDA UDI	Class II	Active
IntuBrite	1024.C2017.C	FDA UDI	Class I	Active
IntuBrite Sterile	S01-6020.C.6016.C	FDA UDI	Class I	Active
NeoCheck	ZNCC4501HP-10	FDA UDI	Class II	Active
Iradimed Pediatric Capnography Cannula	1842P	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFUO-60	FDA UDI	Class II	Active
IntuBrite	6017.C	FDA UDI	Class I	Active
Salter AIRE Elite	SO-1062BK	FDA UDI	Class I	Active
Parker Flex-Tip	H-PFTVVC-85	FDA UDI	Class II	Active
IntuBrite	1012	FDA UDI	Class I	Active
Vital Signs™	5640	FDA UDI	Class II	Active
IntuBrite	1040.C	FDA UDI	Class I	Active
Parker	H-PFOL-55	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFNU-50	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFOC-30	FDA UDI	Class II	Active
IntuBrite Sterile	S01-2016.C	FDA UDI	Class I	Active
Parker	H-PSTDR-28	FDA UDI	Class II	Active
Parker	H-PFLP-45	FDA UDI	Class II	Active
Cannulaide	HF102-0-25	FDA UDI	Class I	Active
DuraCheck	ZDC4001HP-10	FDA UDI	Class II	Active
Cannulaide	CA103-0-25	FDA UDI	Class II	Active
Sticky Whiskers	SW102-0-25	EUDAMEDFDA UDI	Class I	Active
Parker	H-PFNU-35	FDA UDI	Class II	Active
O2 Cannula	SFT2611	FDA UDI	Class I	Active
Parker Flex-Tip	H-PFHV-85	FDA UDI	Class II	Active
Salter AIRE Elite	SO-1988GN	FDA UDI	Class II	Active
Parker	H-PFNC-70	FDA UDI	Class II	Active
O2 Cannula	001366	FDA UDI	Class I	Active
DuraCheck	ZDC4101HP-10	FDA UDI	Class II	Active
Salter AIRE Elite	SO-1833BE	FDA UDI	Class II	Active
IntuBrite Sterile	S01-6034.C	FDA UDI	Class I	Active
IntuBrite Sterile	S01-1030.C	FDA UDI	Class I	Active
O2 Cannula	001322U	FDA UDI	Class I	Active
Parker	H-PTCL-40	FDA UDI	Class II	Active
O2 Cannula	001350	FDA UDI	Class I	Active
IntuBrite	1032.C2015.C	FDA UDI	Class I	Active
Parker Flex-Tip	H-PFOU-75	FDA UDI	Class II	Active
Parker Flex-Tip	H-PTCY-80	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFOC-85	FDA UDI	Class II	Active
O2 Cannula	001327U	FDA UDI	Class I	Active
NebuTech®	8966-7	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFOU-50	FDA UDI	Class II	Active
Gas Sampling Lines	0513	FDA UDI	Class II	Active
Parker Flex-Tip	H-PFOC-50	FDA UDI	Class II	Active
Salter ETCo2/O2 Cannula	4MSF1SOFT-L-7-6	FDA UDI	Class II	Active
ThermiSense	5700A3-0-1	FDA UDI	Class II	Active
ThermiSense	5700PE-0-1	FDA UDI	Class II	Active
Salter AIRE Elite	SO-938BE	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.