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Code · CFR · Title 21 — Food and Drugs · Part 201 — Labeling · § 201.328

§ 201.328. Labeling of medical gas containers.

622 words·~3 min read·/us/cfr/t21/s§ 201.328·

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(a)Portable cryogenic medical gas containers. For the purposes of this section a portable cryogenic medical gas container is one that is capable of being transported and is intended to be attached to a medical gas supply system within a hospital, health care entity, nursing home, other facility, or home health care setting, or is used to fill small cryogenic gas containers for use by individual patients. The term excludes cryogenic containers that are not designed to be connected to a medical gas supply system, e.g., tank trucks, trailers, rail cars, or small cryogenic gas containers for use by individual patients (including portable liquid oxygen units as defined at § 868.5655 of this chapter).
(1)Each portable cryogenic medical gas container must be conspicuously marked with a 360° wraparound label identifying its contents. Such label must meet the requirements of § 213.94(e)(3) of this chapter and the following additional requirements.
(i)If the container holds a single gas, the name of the gas held in the container must be printed on the label in one of the following ways:
(A)Using lettering that appears in the color designated for the gas in paragraph
(c)of this section and that is printed against a white background, or
(B)Using lettering that appears in white against a background that is painted in the color for the gas designated in paragraph
(c)of this section.
(ii)The lettering for the name of the gas on the label must be at least 2 inches high.
(iii)The name of the gas must be printed continuously around the label and be capable of being read around the entire container.
(iv)The label must be on the sidewall of the container, as close to the top of the container as possible but below the top weld seam.
(v)A portable cryogenic medical gas container may only be colored in the color or colors designated in paragraph
(c)of this section if the gas or gases held within the container correspond to that color or those colors.
(2)A label on the container (either the 360° wraparound label required in paragraph (a)(1) of this section or a separate label) must include, in conspicuous lettering, the phrase “For Medical Use”, “Medical Gas,” or some similar phrase that indicates the gas is for medical use.
(b)High-pressure medical gas cylinders. Each high-pressure medical gas cylinder must be colored on the shoulder portion of the cylinder in the color or colors designated in paragraph
(c)of this section. The color or colors must be visible when viewed from the top of cylinder.
(c)Medical gas colors. The colors required to identify medical gases under paragraph
(a)and
(b)of this section are: Medical gas Color Medical AirYellow. Carbon DioxideGray. HeliumBrown. NitrogenBlack. Nitrous OxideBlue. OxygenGreen. Mixture or BlendColors corresponding to each component gas.
(d)Statement identifying owner or return address of medical gas containers. Notwithstanding § 201.1, a container filled with a designated medical gas (as defined in § 201.161(c)(1)) or medically appropriate combination of designated medical gases may bear a statement identifying the name of the owner of the container or the address to which the container should be returned after use. Such statement may appear on a separate sticker or decal. If the owner of the medical gas container is not the manufacturer, packer, or distributor of the designated medical gas or medically appropriate combination of designated medical gases, that shall be clearly stated on the container. The addition of such statement shall not cause the owner of the cylinder to be a “relabeler” for purposes of registration and listing under part 207 of this chapter. [81 FR 81696, Nov. 18, 2016, as amended at 89 FR 51769, June 18, 2024]
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§ 201.328
Labeling of medical gas containers.
Fed. Reg.×2
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