baxter PCA II - Page 65

Specifications
Infusion Pump Medical Device Tracking Fact Sheet
1. Scope
Per 21 CFR Part 821, infusion pumps have been categorized by the
FDA as devices which must be tracked. fused within a device user
facility (i.e., hospital, nursing home), tracking zo the user facility is
required. [fthe infusion pump is used outside a device user facility, the
distributor who provides the device to a patient must keep records of
the infusion pump's location and subsequently report this information
to the manufacturer.
2. Effective Date
August 29, 1993
Definitions
User Facility Hospital, Nursing Home, Ambulatory Surgical
Facility, or Diagnostic Facility
Distributor
Any entity who furthers the distribution of a device
from the original place of manufacture co che person
who makes delivery or sale to the ultimate user, e. the
final or multiple distributor, but who does not repack-
age or otherwise change the container, wrapper or
labeling of the device or device package
Final Distributor Any entity who distributes a tracked device intended
for use by a SINGLE patient over the useful life of the
device.
Multiple Distributor
Any entity thar distributes a tracked device intended
for use by MORE THAN ONE patient over the useful
life of the device.