21 CFR 868.1100
§ 868.1100 Arterial blood sampling kit.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 868.1100, § 868.1100 Arterial blood sampling kit, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89710
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Full text
(a) 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.
(b) Classification. 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.