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Sign in to claim this brandSALTER 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
- —
- —
- [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 4 of 20| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Salter AIRE Elite | 8350-8906 | FDA UDI | Class I | Active |
| Parker Flex-Tip | H-PFTDL-32 | FDA UDI | Class II | Active |
| Parker | H-PFNU-40 | FDA UDI | Class II | Active |
| Parker | H-PFHV-65 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PTCL-55 | FDA UDI | Class II | Active |
| ThermiSense | 5700B-0 | FDA UDI | Class II | Active |
| Parker | H-PFOU-30 | FDA UDI | Class II | Active |
| Comfort Soft Plus | 0430 | FDA UDI | Class II | Active |
| O2 Cannula | 002601 | FDA UDI | Class I | Active |
| Parker | H-PFRU-30 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFOL-35 | FDA UDI | Class II | Active |
| Flexi-Soft | OTC-101-7 (QTY 1) | FDA UDI | Class I | Active |
| Salter AIRE Elite | SO-1408GN | FDA UDI | Class II | Active |
| CapnoVue | 2004-A 4737-14-0-50 | FDA UDI | Class I | Active |
| Parker Flex-Tip | H-PFOU-80 | FDA UDI | Class II | Active |
| CapnoVue | 1004-A 4727-14-0-50 | FDA UDI | Class I | Active |
| Parker | H-PFUO-60 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFLP-35 | FDA UDI | Class II | Active |
| Salter AIRE Elite | SO-1888GN | FDA UDI | Class II | Active |
| IntuBrite Sterile | S01-1031.C | FDA UDI | Class I | Active |
| Parker Flex-Tip | H-PFOL-40 | FDA UDI | Class II | Active |
| Parker | H-PFOU-50 | FDA UDI | Class II | Active |
| Parker | H-PFST-55 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFNU-55 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFOC-65 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFOC-80 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFTDL-39 | FDA UDI | Class II | Active |
| CapnuVue | 4723-7-0 | FDA UDI | Class II | Active |
| Philips MR Patient Care Sample Line | P183241 | FDA UDI | Class II | Active |
| Cannulaide | HF104-0-25 | FDA UDI | Class I | Active |
| IntuBrite | 2015.C | FDA UDI | Class I | Active |
| Parker Flex-Tip | H-PFNC-80 | FDA UDI | Class II | Active |
| IntuBrite | 1000 | FDA UDI | Class I | Active |
| Cannulaide | CA110-0-1 | FDA UDI | Class II | Active |
| Parker | H-PFNC-50 | FDA UDI | Class II | Active |
| O2 Tubing | 001304U | FDA UDI | Class I | Active |
| IntuBrite | 1020.C | FDA UDI | Class I | Active |
| Parker | H-PFOU-55 | FDA UDI | Class II | Active |
| IntuBrite Sterile | S01-1032.C.2016.C | FDA UDI | Class I | Active |
| IntuBrite | 2011.C | FDA UDI | Class I | Active |
| CapnoVue | 47MSF8-14-13 | FDA UDI | Class II | Active |
| IntuBrite | 1032.C2017.C | FDA UDI | Class I | Active |
| Parker Flex-Tip | H-PFOL-60 | FDA UDI | Class II | Active |
| ThermiSense | 5700A5-0 | FDA UDI | Class II | Active |
| Salter AIRE Elite | SO-1985GN | FDA UDI | Class II | Active |
| IntuBrite | 6029.C | FDA UDI | Class I | Active |
| Parker Flex-Tip | H-PFST-55 | FDA UDI | Class II | Active |
| Salter ETCo2/O2 Cannula | 4MSF2SOFT-L-PED-7-6 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFUO-90 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFNC-70 | FDA UDI | Class II | Active |
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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. |