21 CFR 868.1100 — Arterial Blood Sampling Kit
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1100
Identification
An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CBT | Arterial Blood Sampling Kit | 1 | 58 | |
| OFZ | Blood Specimen Collection Kit (Excludes Hiv Testing) | 1 | 0 |
