OFZ · Blood Specimen Collection Kit (Excludes Hiv Testing)
Anesthesiology · 21 CFR 868.1100 · Class 1
Overview
| Product Code | OFZ |
|---|---|
| Device Name | Blood Specimen Collection Kit (Excludes Hiv Testing) |
| Regulation | 21 CFR 868.1100 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
