DeviceClearance

Product code PWH— General Hospital

BD Alaris Pump Epidural Infusion Set

Classification name
Administrations Sets With Neuraxial Connectors
Device class
Class 2
Regulation
21 CFR 880.5440
Advisory panel
General Hospital
Total cleared
4
First cleared
Most recent

FDA classification definition

“The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.”

— U.S. Food and Drug Administration, device classification record for product code PWH under 21 CFR 880.5440, via openFDA

Market context for product code PWH

FDA has cleared 4 devices under product code PWH between 2017 and 2023, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PWH

Adverse events under product code PWH

product code PWH
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PWH

Data sourced from openFDA. This site is unofficial and independent of the FDA.