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General product and regulatory information only; this is not medical advice and does not describe how to perform a blood draw.
A phlebotomy cart is a wheeled workstation that carries blood collection supplies to the point of collection. A phlebotomy tray is a different thing: the U.S. FDA lists a “tray, blood collection” as a regulated device (product code GJE, Class II), while the wheeled cart that carries it is furniture. This guide separates the two, lists what a cart typically holds, and names the rules that apply to the sharps container and specimen containers on it.
Purpose and setting: cart versus tray
What is a phlebotomy cart?
A phlebotomy cart is a mobile unit that keeps collection supplies together and moves them from patient to patient. Manufacturers describe typical carts as having casters and a push handle, drawers, a wipeable work surface, mounts for a sharps container and glove box holders, and sometimes a height-adjustable top, a computer or label printer, and a lock (key, push-button or electronic) (AliMed, checked 2026-10-30; a manufacturer description, not a standard).
What is a phlebotomy tray?
A phlebotomy tray is the portable set of collection supplies, small enough to be carried by hand or set on a cart. In U.S. device regulation the relevant entry is “tray, blood collection”, product code GJE, regulated under 21 CFR 862.1675, Class II, reviewed through the 510(k) pathway, Clinical Chemistry panel (FDA Product Classification Database, checked 2026-10-30). The regulation describes a blood specimen collection device as one that collects and handles blood specimens and separates serum from nonserum (cellular) components before testing, and says the generic type may include collection tubes, vials, systems, serum separators, blood collection trays or vacuum sample tubes (21 CFR 862.1675(a), checked 2026-10-30).
Is a phlebotomy cart regulated by the FDA?
The FDA classification described here belongs to the blood collection tray (GJE), not to a wheeled cart, and this page does not assign an FDA class to a cart. For the equipment around the draw, see Phlebotomy Chair: Types, Sizes and FDA Classification.
Checklist table
The rows below are limited to items tied to a regulation or to a manufacturer’s description of typical carts. They are not a procedure and do not set quantities, which depend on the facility’s own protocols and the supplies’ instructions for use. For the station-level supply list, including needle and tube range, see the Phlebotomy Lab Supply Checklist.
| Category | Item | Why it is on the list | Notes |
|---|---|---|---|
| Collection | Blood collection tubes and systems | 21 CFR 862.1675(a) names tubes, vials, systems and vacuum sample tubes as part of the generic device type. | Check the manufacturer’s expiry date on each tube. |
| Sharps and waste | Sharps container mounted on the cart | OSHA 1910.1030(d)(4)(iii)(A) requires contaminated sharps to go into containers that are closable, puncture resistant, leakproof on sides and bottom, and labeled or color-coded. | Typical carts offer a mount for the container (AliMed). |
| Specimen handling | Leakproof specimen container or transport bag | OSHA 1910.1030(d)(2)(xiii) requires blood specimens to be placed in a container that prevents leakage during collection, handling, processing, storage, transport and shipping. | Container type follows the facility’s lab protocol. |
| PPE | Glove box holders | Typical carts include holders so gloves are within reach (AliMed). | PPE selection follows the facility’s exposure control plan. |
| Labeling and documentation | Label printer or computer (optional) | Listed by the manufacturer as an optional cart feature (AliMed). | Optional; not all carts have one. |
| Security | Lockable drawer | Typical carts offer key, push-button or electronic locks, with a lockable top drawer for controlled supplies (AliMed). | Lock type varies by model. |
What varies between carts
Manufacturer descriptions show the main differences are in the furniture, not the regulated contents: drawer layout, a fixed or height-adjustable work surface, whether a computer or label printer is mounted, and the lock type (AliMed, checked 2026-10-30). A tray without a cart can be carried by hand, and a station keeps its supplies in one place. Which arrangement suits a given setting is a decision for the facility’s own protocols.
Storage, expiry and restocking
Check each tube’s expiry date as printed by its manufacturer, and follow the manufacturer’s instructions for use for storage. The CDC’s Standard Precautions page (page dated April 3, 2024; checked 2026-10-30) tells healthcare personnel to properly handle, clean and disinfect patient care equipment and instruments, and a shared cart is equipment that moves between patients. Under OSHA, contaminated sharps are not to be bent, recapped or removed, except where the standard’s exceptions apply (29 CFR 1910.1030(d)(2)(vii)).
Standards that apply
- 21 CFR 862.1675, blood specimen collection device: Class II; FDA product code GJE for the tray (checked 2026-10-30).
- OSHA 29 CFR 1910.1030, Bloodborne Pathogens: effective March 6, 1992 (56 FR 64004); latest listed amendment 84 FR 21598 (May 14, 2019). See also sharps disposal regulations and the bloodborne pathogens exposure control plan.
- CDC Standard Precautions: handle needles properly, review the Sharps Safety for Healthcare Settings workbook, follow safe injection practices.
Related: What is a tourniquet?
FAQ
What is a phlebotomy tray?
It is the set of blood collection supplies the FDA lists as “tray, blood collection” (product code GJE), a Class II device under 21 CFR 862.1675.
Is a phlebotomy cart regulated by FDA?
The FDA entry cited here covers the tray, not a wheeled cart. The sharps container on a cart is covered by OSHA 29 CFR 1910.1030(d)(4)(iii)(A).
What goes in a phlebotomy cart?
Typical carts carry collection tubes and systems, a mounted sharps container, glove holders and, on some models, a label printer or computer. See the checklist table above.
Sources
- eCFR, 21 CFR 862.1675, ecfr.gov, checked 2026-10-30.
- FDA Product Classification Database, code GJE, accessdata.fda.gov, checked 2026-10-30.
- OSHA, 29 CFR 1910.1030, osha.gov, checked 2026-10-30.
- CDC, Standard Precautions, cdc.gov, page dated April 3, 2024, checked 2026-10-30.
- AliMed, phlebotomy carts article (manufacturer description), alimed.com, checked 2026-10-30.
