On-body Injector
General Hospital · 21 CFR 880.5860
An On-Body injector is a prescription device adhered to the body intended to inject single or multiple doses of medicinal product from a cartridge or reservoir in accordance with FDA approved labeling. The device can be used by health care professionals or for self-injection by the patient. It should not be used for the infusion of drugs.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
11 firms currently registered for this product code
Enable Injections
Cincinnati, OH, US
Isomedix Operations Inc
GROVEPORT, OH, US
Isomedix Operations, Inc.
Libertyville, IL, US
West Pharmaceutical Services Arizona, Inc.
Tempe, AZ, US
Enable Injections
Cincinnati, OH, US
Lts Device Technologies
Netanya Central, IL
West Pharmaceutical Services Az, Inc.
SCOTTSDALE, AZ, US
Apellis
Waltham, MA, US
A+ Secure Packaging
La Vergne, TN, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.