Nellcor Puritan Bennett France Dvpt.
FranceFDA applicant, unverified
- Devices
- 2
What Nellcor Puritan Bennett France Dvpt. makes
The company manufactures single-use nasal cannulas, including standard oxygen delivery models (e.g., Goodnight 418A, Goodnight 418P) and variants with antimicrobial coatings (e.g., Silverlining 2) or gel-based cushioning (e.g., Goodnight 418G). These devices are designed for continuous or intermittent oxygen therapy in clinical and homecare settings, with variations to reduce irritation or infection risk.
All listed devices fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) clearance via the FDA. The portfolio is exclusively authorised through the FDA 510(k) pathway, with no presence in other regulatory registries or jurisdictions. The company is headquartered in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Nellcor Puritan Bennett, Goodknight 418g Ref K991150
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nellcor Puritan Bennett France Dvpt. have in the registry?
The registry currently lists 2 devices for Nellcor Puritan Bennett France Dvpt.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nellcor Puritan Bennett France Dvpt.'s devices?
Among its 2 most recently registered devices, Nellcor Puritan Bennett France Dvpt. has devices listed in FDA 510(k) (2 devices).
What risk classes do Nellcor Puritan Bennett France Dvpt.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Nellcor Puritan Bennett France Dvpt.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nellcor Puritan Bennett France Dvpt. in the registry?
The most recently registered devices listed for Nellcor Puritan Bennett France Dvpt. include MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 and NELLCOR PURITAN BENNETT, GOODKNIGHT 418G.