21 CFR 880.5570 — Needle, Hypodermic, Single Lumen
General Hospital (HO) · Part 880 Subpart F—General Hospital and Personal Use Therapeutic Devices · § 880.5570
Identification
A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 2 | 689 | 3rd Party |
| MHC | Needle, Interosseous | 2 | 2 | Implant |
| MMK | Container, Sharps | 2 | 112 | 3rd Party |
| NKK | Needle, Hypodermic, Single Lumen, Reprocessed | 2 | 0 | 3rd Party |
| PTI | Non-Coring (Huber) Needle | 2 | 13 | |
| PVZ | Non-Stainless Steel Needle | 2 | 1 | 3rd Party |
| PWY | Lumbar Puncture Tray (Adult & Pediatric) | 2 | 0 | |
| PXB | Percutaneous Introducer Kit | 2 | 0 | |
| PXI | Thoracentesis Tray | 2 | 0 | |
| PXL | Venipuncture Kit | 2 | 0 | |
| QMT | Prep Kit Vaccine Injection | 2 | 0 | |
| QNS | Low Dead Space Needle, Single Lumen, Hypodermic | 2 | 3 | |
| QYM | Ophthalmic Needle | 2 | 2 | |
| SCL | Allergen And Vaccine Delivery Needles | 2 | 25 | 3rd Party |
