FDA Medical Device Classifications
Single Use Device (SUD) - items provided "sterile" to minimize contamination from patient to patient; not intended for multiple use on a single patient.

Single Patient Use - items that may be reused multiple times on the same patient, then disposable.

Reusable Multi-Patient Use - items that may be reused on multiple patients, with high level disinfection and cleaning, then disposable.

The following Respironics masks are labeled as Reusable Multi-Patient Use:

ComfortGel™
ComfortFull™ 2
ComfortLite™ 2
ComfortLite™
ComfortSelect™
ComfortClassic™
Profile™ Lite
Simplicity™ Nasal Mask
Total™ Face Mask

Print page