21 CFR 880.5860 — Syringe, Piston
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5860
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FMF | Syringe, Piston | 2 | 749 | 3rd Party |
| MEG | Syringe, Antistick | 2 | 163 | 3rd Party |
| MZM | Fibrin Sealant Preparation Device | 2 | 0 | |
| NKN | Syringe, Piston, Reprocessed | 2 | 0 | |
| NSC | Injector, Pen | 2 | 1 | |
| PQX | Epinephrine Syringe | 2 | 2 | |
| PUR | Vacuum Syringe | 2 | 2 | |
| QBL | Piston Syringe Lever | 2 | 3 | 3rd Party |
| QDM | Midazolam Syringe | 2 | 0 | |
| QEH | Piston Syringe With Neuraxial Connector Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact | 2 | 5 | |
| QLF | On-Body Injector | 2 | 0 | SaMD |
| QLY | Ophthalmic Syringe | 2 | 7 | |
| QNQ | Low Dead Space Piston Syringe | 2 | 12 | |
| QOG | Injection Data Capture Device | 2 | 7 | SaMD |
