Respiratory Humidifier For Emergency Use

QOP · Not classified · Unknown

Classification

FDA Product Code: QOP
Device class: Not classified
Regulation: —
Review panel: EN
Medical specialty: Unknown
Submission type: 8
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device for use during declared public health emergency.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown