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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
—
Phone
+1-269-873-0502
PRRC Contact
Robert Yamashita
EUDAMED SRN
US-MF-000007934
FDA FEI Number
3004748541
DUNS Number
022721133

Catalogue (988)

Page 7 of 20
DeviceModel / ReferenceRegistriesClassStatus
Parker H-PFOC-65
FDA UDI
Class IIActive
Parker Flex-Tip H-PFST-75
FDA UDI
Class IIActive
Comfort Soft Plus 0173
FDA UDI
Class IActive
Parker H-PFOL-30
FDA UDI
Class IIActive
Parker Flex-Tip H-PFTDL-37
FDA UDI
Class IIActive
Parker Flex-Tip H-PFHV-35
FDA UDI
Class IIActive
Parker Flex-Tip H-PFNC-60
FDA UDI
Class IIActive
NeoCheck ZNCC4801HP-10
FDA UDI
Class IIActive
Parker Flex-Tip H-PFNU-30
FDA UDI
Class IIActive
Parker H-PFTDL-41
FDA UDI
Class IIActive
Parker H-PSTDR-37
FDA UDI
Class IIActive
Parker H-PFNC-85
FDA UDI
Class IIActive
Parker H-PFHV-45
FDA UDI
Class IIActive
IntuBrite Sterile S01-6033.C
FDA UDI
Class IActive
Parker H-PFLP-55
FDA UDI
Class IIActive
Parker Flex-Tip H-PFHV-60
FDA UDI
Class IIActive
Parker Flex-Tip H-PSTDR-35
FDA UDI
Class IIActive
IntuBrite Sterile S01-6030.C
FDA UDI
Class IActive
Parker H-PTCL-25
FDA UDI
Class IIActive
Parker H-PFNU-60
FDA UDI
Class IIActive
Parker H-PFHV-85
FDA UDI
Class IIActive
ThermiSense 5700T-0-1
FDA UDI
Class IIActive
Salter AIRE Elite SO-1770GN
FDA UDI
Class IIActive
Comfort Soft Plus 0567-RC
FDA UDI
Class IActive
InfuseIT ZIT-3002
FDA UDI
Class IActive
Capnovue 2001-P
FDA UDI
Class IActive
Parker Flex-Tip H-PFLP-90
FDA UDI
Class IIActive
Iradimed Adult Capnography Cannula 1842A
FDA UDI
Class IIActive
Parker H-PFHV-90
FDA UDI
Class IIActive
Parker H-PFOU-85
FDA UDI
Class IIActive
Salter AIRE Elite SO-1773BE
FDA UDI
Class IActive
Grippies GR103P-0-5
FDA UDI
Class IActive
Parker H-PFOL-40
FDA UDI
Class IIActive
O2 Cannula SFT2692
FDA UDI
Class IActive
Parker H-PFOL-35
FDA UDI
Class IIActive
Parker H-PFNU-30
FDA UDI
Class IIActive
Parker Flex-Tip H-PTCY-70
FDA UDI
Class IIActive
Resmed Sleep Apnealink Cannula 70710316
FDA UDI
Class IIActive
Parker Flex-Tip H-PFNU-35
FDA UDI
Class IIActive
Parker Flex-Tip H-PFUO-75
FDA UDI
Class IIActive
IntuBrite 6024.C
FDA UDI
Class IActive
Parker H-PFRC-60
FDA UDI
Class IIActive
Cannula 16SOFTTG-INF-7
FDA UDI
Class IActive
IntuBrite Sterile S01-6031.C
FDA UDI
Class IActive
Iradimed Infant Capnography Cannula 1842I
FDA UDI
Class IIActive
Parker Flex-Tip H-PFHV-80
FDA UDI
Class IIActive
Parker H-PFNC-75
FDA UDI
Class IIActive
Parker H-PTCY-85-90
FDA UDI
Class IIActive
Parker H-PFRC-80
FDA UDI
Class IIActive
ThermiSense 5700E-0
FDA UDI
Class IIActive

Related Companies

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Importers

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Notified Bodies

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Authorities

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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.

DateRecall No.ClassStatusReason
Jun 25, 2014Z-2093-2014—terminated

The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather.

Nov 1, 2013Z-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, 2012Z-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, 2011Z-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, 2011Z-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.