21 CFR 868.1170 — Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1170
Identification
An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | 2 | 10 | 3rd Party |
Special Controls
CBZ — Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
eCFR
CBZ — Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”
Ecfr Llm
