FDA Device Establishments · JSON-LD · Markdown
FEI 3010882708 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3010882708 |
|---|---|
| Owner / Operator | NextPhase Medical Devices LLC Mexico (#10046837) |
| Address | Tomas Alba Edison 19002, Parque Industrial Tomas Alba Edison, CP, TIJUANA Baja California, 22330, MX |
| Mandatory US Agent | NextPhase Medical Device, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | CBK, DQA |
| Regulation § (21 CFR) | 868.5895, 870.2700 |
| Proprietary names | CANNULA, O2 CO2, INF, 10, ZOLL LOFLO (3569INF-00); AIRWAY, DEHUM TBG, ADU PED, ZOLL LOFLO, 10 (3573ADU-00); CANNULA, O2 CO2, PED, ZOLL LOFLO, 10 (3569PED-00); AIRWAY, PEDIATRIC INFANT, ZOLL LOFLO, 10 (3572INF-00); CANNULA, CO2, PED, ZOLL LOFLO, 10 (3568PED-00); AIRWAY, ADULT PEDIATRIC, ZOLL LOFLO, 10 (3572ADU-00); AIRWAY, DEHUM TBG, PED INF, ZOLL LOFLO, 10 (3573INF-00); CANNULA, CO2 ORAL, ADU, ZOLL LOFLO, 10 (3570ADU-00); CANNULA, O2 CO2 ORAL, ADU, ZOLL LOFLO, 10 (3571ADU-00); CANNULA, CO2, ADU, ZOLL LOFLO, 10 (3568ADU-00) |
Source: openFDA. Public-domain (CC0).