21 CFR 880.5200 — Catheter, Umbilical Artery
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5200
Identification
An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FOS | Catheter, Umbilical Artery | 2 | 34 | 3rd Party |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 503 | 3rd Party |
| LRS | I.V. Start Kit | 2 | 30 | |
| NGT | Saline, Vascular Access Flush | 2 | 41 | |
| NZW | Heparin, Vascular Access Flush | 2 | 7 | |
| NZX | Water, Vascular Access Flush | 2 | 0 | |
| OWL | Peripheral Catheter Insertion Kit | 2 | 0 | |
| PEF | Heparin Flush In 0.45% Sodium Chloride | 2 | 0 | |
| PEZ | Central Venous Catheter Dressing Change Kit | 2 | 0 | |
| PND | Midline Catheter | 2 | 13 | |
| PXJ | Umbilical Catheter Insertion Tray | 2 | 0 | |
| QTI | Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device | 2 | 1 | |
| SEF | Central Venous Catheter With Manual Insertion System | 2 | 1 |
