REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION
Device Facts
| Record ID | K952406 |
|---|---|
| Device Name | REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION |
| Applicant | Contour Fabricators of Florida, Inc. |
| Product Code | KYZ · General Hospital |
| Decision Date | Aug 7, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6960 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.
