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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 12 of 20| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Parker | H-PFLP-65 | FDA UDI | Class II | Active |
| IntuBrite Sterile | S01-1020.C2016.C | FDA UDI | Class I | Active |
| ThermiSense | 5751-2 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PSTDL-39 | FDA UDI | Class II | Active |
| IntuBrite Sterile | S01-6023.C | FDA UDI | Class I | Active |
| Parker | H-PFEC-60 | FDA UDI | Class II | Active |
| IntuBrite | 6034.C | FDA UDI | Class I | Active |
| NebuTech | 8990TG-7-50 | FDA UDI | Class II | Active |
| Salter AIRE Elite | SO-1647BK | FDA UDI | Class I | Active |
| Grippies | GR101P-0-5 | FDA UDI | Class I | Active |
| CapnuVue | 4737TG-14-0 | FDA UDI | Class II | Active |
| CapnuVue | 4721-7-0 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFRC-55 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PMLT-60 | FDA UDI | Class II | Active |
| O2 Tubing | 001306U | FDA UDI | Class I | Active |
| Parker | H-PFUO-85 | FDA UDI | Class II | Active |
| ThermiSense | 5700PS20-0 | FDA UDI | Class II | Active |
| Vital Signs™ | 5640I | FDA UDI | Class II | Active |
| IntuBrite | 1032.C | FDA UDI | Class I | Active |
| Salter AIRE Elite | SO-1791GN | FDA UDI | Class II | Active |
| IntuBrite Sterile | S01-1032.C.2017.C | FDA UDI | Class I | Active |
| Parker | H-PFTDL-37 | FDA UDI | Class II | Active |
| Capnovue | 1001-A | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFLP-80 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PSTDR-37 | FDA UDI | Class II | Active |
| Salter AIRE Elite | SO-1737BY | FDA UDI | Class II | Active |
| IntuBrite | 1033.C | FDA UDI | Class I | Active |
| Parker Flex-Tip | H-PFOU-85 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFOC-90 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFST-50 | FDA UDI | Class II | Active |
| Salter AIRE Elite | SO-1778BE | FDA UDI | Class II | Active |
| Parker | H-PFST-80 | FDA UDI | Class II | Active |
| Comfort Soft Plus | 0918 | FDA UDI | Class II | Active |
| Salter AIRE Elite | SO-1769BK | FDA UDI | Class I | Active |
| IntuBrite | 1023.C2015.C | FDA UDI | Class I | Active |
| Parker Flex-Tip | H-PFLP-30 | FDA UDI | Class II | Active |
| Capnovue | 2001-A | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFST-60 | FDA UDI | Class II | Active |
| Parker Flex-Tip | H-PFRC-85 | FDA UDI | Class II | Active |
| CapnuVue | 4737TG-7-0 | FDA UDI | Class II | Active |
| Salter AIRE Elite | SO-1447BE | FDA UDI | Class II | Unknown |
| DuraCheck | ZDC4221HP-10 | FDA UDI | Class II | Active |
| DuraCheck | ZDC4121HP-10 | FDA UDI | Class II | Active |
| Parker | H-PFUO-20 | FDA UDI | Class II | Active |
| Parker | H-PFNC-90 | FDA UDI | Class II | Active |
| Parker | H-PFLP-85 | FDA UDI | Class II | Active |
| Salter AIRE Elite | SO-1055RD | FDA UDI | Class II | Active |
| IntuBrite | 6021.C | FDA UDI | Class I | Active |
| Parker | H-PFTDL-35 | FDA UDI | Class II | Active |
| IntuBrite Sterile | S01-6017.C | 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. |