Empty IV Bag: What It Is, Parts, Materials and Sizes

This page describes products and general use; it is not medical advice.

An empty IV bag is a container sold without fluid in it: the bag, its ports and (often) a transfer set, intended to hold a mixture prepared by a pharmacy or clinical team and later connected to an IV administration set. Who uses it: hospital pharmacy and compounding staff, infusion and clinic buyers, and students learning how IV containers are regulated. This guide covers what FDA says an empty bag is, how a cleared example is built, and what its size range looks like.

What is an empty IV bag?

An empty IV bag is a plastic container intended to be filled with a fluid mixture and then administered through an intravascular administration set. In US regulation it falls under the device type “I.V. container”. 21 CFR 880.5025 defines it as “a container made of plastic or glass used to hold a fluid mixture” to be administered to a patient through an intravascular administration set, and classifies it as Class II (performance standards) (21 CFR 880.5025).

One FDA-cleared example, the Valmed EVA TPN bag (510(k) K101412, product code KPE), is described in its summary as an “empty container for use in compounding and storage of sterile medical solutions such as parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set” (FDA 510(k) summary K101412). The details below describe that cleared product and its named predicates, not every empty bag on the market.

How an empty IV bag is built

According to the K101412 summary, the empty bag is designed to connect to source containers through standard spikes. A transfer set, in configurations from one lead to three leads, can be supplied with the bag. The bag has non-reopening clamps, a medication port and a set port that connects it to an IV administration set. The summary states that the bag is discarded after use.

Part	What the FDA summary says
Bag	A copolymer of ethylene and vinyl acetate (EVA); listed as phthalate-free, with no components made of natural rubber latex
Transfer set	One-lead to three-lead configurations; tubing made of polyvinyl chloride (PVC)
Clamps	Non-reopening clamps
Medication port	Port for additional medications
Set port	Connects the container to an intravascular administration set
Use life	Single use; the bag is discarded after use

The sponsor gives its reason for EVA as preserving the stability of fat in the nutritional blend longer. The summary also states that the product was tested against ISO 15747:2003, Plastics containers for intravenous injection.

Types and variants

The summary and its predicate comparison describe variation mainly in the transfer set. The Baxter All-In-One predicate (K090096, K983294) is listed with three-lead and single-lead transfer sets, and the Valmed product with one-lead to three-lead sets.

Variant	Typical use as described	Key difference
Bag with one-lead transfer set	Connects to source containers through standard spikes	One lead
Bag with three-lead transfer set	Same spike connection, with a three-lead set	Three leads

Sizes that matter

The values below come from the FDA summary and belong to the named cleared products rather than to empty bags in general.

Product in the summary	Stated volume capacity
Valmed EVA TPN bag (K101412)	150 mL to 5000 mL
Baxter All-In-One container (predicate)	Presentations up to 1 L, 2 L, 3 L and 4 L

What to check on an empty IV bag

Three points define an empty bag in regulatory terms. First, the regulatory identity: an empty bag is an I.V. container under 21 CFR 880.5025, Class II. Second, intended use: the cleared example is for compounding and storage of parenteral nutrition solutions before and during administration, so that stated intended use is what the clearance covers. Third, materials: the summary lists the bag material (EVA) separately from the transfer set tubing (PVC), so an “EVA bag” is not the same statement as a PVC-free system. The same distinction between container film and tubing appears in the guide to Viaflex IV bags and PVC versus non-PVC film.

Handling and labeling basics

• The K101412 summary describes the bag as single use, discarded after use.
• It lists non-reopening clamps, a medication port and a set port as features of the bag.
• Connection to the patient is through an intravascular administration set at the set port; see the guides to Y-site connectors on IV tubing and the IV infusion pump for what sits downstream.
• Filling and compounding practices are set by the product’s instructions for use and the organization’s own policies, not by this page.

Common mistakes

• Treating an empty bag as a premixed product. A premixed bag already contains its fluid; an empty bag is only the container (see IV bag fluid types and stocking for filled bags).
• Reading “EVA bag” or “phthalate-free” as covering the whole set: in the cleared example the transfer set tubing is PVC.
• Assuming the sizes of one cleared product apply to every empty bag. The figures above are specific to the products named in the FDA summary.

FAQ

What is an empty IV bag used for?

It holds a fluid mixture that is prepared separately and then given through an IV administration set. The cleared example in K101412 is intended for compounding and storage of parenteral nutrition solutions before and during administration.

What are empty IV bags made of?

In the cleared example, the bag is an ethylene vinyl acetate copolymer and the transfer set tubing is PVC. Other products may differ; 21 CFR 880.5025 allows plastic or glass containers.

What sizes do empty IV bags come in?

The Valmed bag in K101412 ranges from 150 mL to 5000 mL, and the Baxter predicate is listed up to 4 L.

What is the difference between an empty and a premixed IV bag?

An empty bag is supplied as a container only, with ports and often a transfer set; a premixed bag is supplied already filled. Premixed bags are covered in the Viaflex bag guide.

Are empty IV bags regulated?

Yes. FDA classifies the I.V. container as Class II (performance standards) under 21 CFR 880.5025, with product code KPE in the K101412 summary.

Infusion containers are listed in the IV bags category at lac.us.

Sources

• 21 CFR 880.5025, I.V. container: https://www.law.cornell.edu/cfr/text/21/880.5025 (checked 2026-10-30).
• FDA 510(k) Summary K101412, Valmed s.r.l., EVA TPN bag: https://www.accessdata.fda.gov/cdrh_docs/pdf10/K101412.pdf (checked 2026-10-30).