FDA Device Establishments · JSON-LD · Markdown
FEI 1219324 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 1219324 |
|---|---|
| Owner / Operator | Philips Medical Systems International BV (#1217116) |
| Address | 3000 Minuteman Rd., Andover, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | CCK |
| Regulation § (21 CFR) | 868.1400 |
| Proprietary names | Respironics Alice, LoFlo, C5 Sidestream Module; Respironics LoFlo Sidestream CO2 Module for Goldway; LoFlo Module - RoHS - Private Label; Respironics LoFlo Sidestream CO2 Module; Carescape CO2 - LoFlo; Respironics LoFlo Sidestream CO2 Module for GE; C5 LoFlo Sidestream Module; LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL; LoFlo CO2 Sampling Cannula PEDIATRIC NASAL; LoFlo CO2 Sampling O2 Delivery Cannula INFANT/NEONATAL NASAL |
Source: openFDA. Public-domain (CC0).