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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 17 of 20| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| IntuBrite | 1021.C2016.C | FDA UDI | Class I | Active |
| Parker | H-PFUO-80 | FDA UDI | Class II | Active |
| Parker | H-PFST-40 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFOL-55 | FDA UDI | Class II | Active |
| IntuBrite | 6031.C | FDA UDI | Class I | Active |
| Parker | H-PTCL-50 | FDA UDI | Class II | Active |
| IntuBrite Sterile | S01-1023.C | FDA UDI | Class I | Active |
| Parker Flex-Tip | H-PFNC-75 | FDA UDI | Class II | Active |
| Parker | H-PFUO-25 | FDA UDI | Class II | Active |
| IntuBrite Sterile | S01-1039.C | FDA UDI | Class I | Active |
| Parker | H-PFLP-30 | FDA UDI | Class II | Active |
| Salter AIRE Elite | SO-1426GN | FDA UDI | Class II | Active |
| ThermiSense | 5700-0 | FDA UDI | Class II | Active |
| Parker | H-PFNC-45 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFTVVC-60 | FDA UDI | Class II | Active |
| Salter AIRE Elite | 8352-8924-7-1 | FDA UDI | Class I | Active |
| IntuBrite Sterile | S01-1024.C2015.C | FDA UDI | Class I | Active |
| ThermiSense | 5742-7-7 | FDA UDI | Class II | Active |
| Parker | H-PFOU-70 | FDA UDI | Class II | Active |
| Salter AIRE Elite | SO-1088GN | FDA UDI | Class II | Active |
| CapnuVue | 4727TG-14-0 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFNU-75 | FDA UDI | Class II | Active |
| InfuseIT | ZIT-1020 | FDA UDI | Class I | Active |
| Parker | H-PFNC-55 | FDA UDI | Class II | Active |
| Philips MR Patient Care Sample Line | P183261 | FDA UDI | Class II | Active |
| Flexi-Soft | OTC-101-4 (QTY 1) | FDA UDI | Class I | Active |
| Parker Flex-Tip | H-PFRC-70 | FDA UDI | Class II | Active |
| IntuBrite | 1022.C | FDA UDI | Class I | Active |
| DuraCheck | ZDC4401HP-10 | FDA UDI | Class II | Active |
| IntuBrite Sterile | S01-6015.C | FDA UDI | Class I | Active |
| Parker | H-PFOC-55 | FDA UDI | Class II | Active |
| CapnuVue | 4733-7-0 | FDA UDI | Class II | Active |
| Salter AIRE Elite | 8353-8924-7-1 | FDA UDI | Class I | Active |
| IntuBrite | 1033.C2015.C | FDA UDI | Class I | Active |
| Salter AIRE Elite | SO-1441BE | FDA UDI | Class I | Active |
| Parker | H-PFRC-55 | FDA UDI | Class II | Active |
| Parker | H-PFNC-40 | FDA UDI | Class II | Active |
| Parker | H-PSTDR-35 | FDA UDI | Class II | Active |
| Salter AIRE Elite | SO-1056GN | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFRU-40 | FDA UDI | Class II | Active |
| CapnoVue | 1002-A 4727TG-7-0-50 | FDA UDI | Class I | Active |
| Parker | H-PFRC-75 | FDA UDI | Class II | Active |
| IntuBrite | 1031.C | FDA UDI | Class I | Active |
| Comfort Soft Plus | 0589 | FDA UDI | Class I | Active |
| Parker | H-PSTDL-32 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFEC-70 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFTVPU-80 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFOL-45 | FDA UDI | Class II | Active |
| Iradimed Sample Line Extension | 1841 | FDA UDI | Class II | Active |
| Salter AIRE Elite | SO-1677BE | FDA UDI | Class I | 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. |