21 CFR 868.5905 — Ventilator, Non-Continuous (Respirator)
Anesthesiology (AN) · Part 868 Subpart F—Therapeutic Devices · § 868.5905
Identification
A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 2 | 456 | |
| NFB | Conserver, Oxygen | 2 | 71 | 3rd Party |
| NHJ | Device, Positive Pressure Breathing, Intermittent | 2 | 24 | |
| NHK | Resuscitator, Manual, Non Self-Inflating | 2 | 10 | Life-Sustaining |
| NMC | Mask, Ventilator, Non-Continuous, Reprocessed | 2 | 0 |