Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
A pressure infusor bag (also called an IV pressure bag, pressure infusor or, in some catalogues, a pressure infuser) is an inflatable cuff that wraps around a bag of IV fluid. When the cuff is inflated, it squeezes the fluid bag so solution flows faster than gravity alone would allow. It is a mechanical accessory that works from the pressure applied to the bag. This page covers what the device is, how its pressure limits differ between designs, and how the FDA classifies it.
What is a pressure infusor bag?
The U.S. FDA defines it in 21 CFR 880.5420: “a device consisting of an inflatable cuff which is placed around an I.V. bag.” Inflating the cuff increases pressure on the bag. It is a Class I device (general controls) and is exempt from premarket notification (510(k)), subject to the limitations in 21 CFR 880.9.
It is not an infusion pump. A pump meters delivery; a pressure infusor only applies pressure to the bag. For devices that actively drive or heat fluid, see the CASRAI guides on the rapid infuser and the blood warmer. For the cannula that fluid ultimately flows through, see what an IV catheter is.
How a pressure infusor bag is built
Manufacturer documentation for the two designs in the table below describes the same basic parts:
- Pressure bag (cuff): the inflatable sleeve that surrounds the IV bag. In the Sun-Med/Novaplus design the IV bag sits between a viewing panel and the pressure bag; the panel is mesh on models VH4005H and VH4010H and clear on V4050 and V4100, and a clear panel lets the user see the fluid level.
- Inflation bulb: a hand bulb that raises pressure (a large oval bulb on the Sun-Med/Novaplus models).
- Gauge (manometer): Sun-Med/Novaplus describes a 360-degree colour-coded gauge with a green target zone.
- Valve or stopcock: a three-way valve that holds or releases pressure. Merit Medical places the stopcock near the bulb for one-handed preparation.
- Hook or hanger: a solution-bag hook and a hanger loop or pole hanger. Merit Medical states its bag hook “secures bag in the event of pressure loss”.
Sun-Med/Novaplus lists these models as latex free, single patient use, disposable and DEHP free. Merit Medical lists its pressure infusor bags as non-sterile.
Types and variants: two documented pressure designs
The table below sets two designs side by side, using values printed in each manufacturer’s documentation.
| Design | Pressure behaviour | Other documented details | Source |
|---|---|---|---|
| Sun-Med / Novaplus pressure infusion bag (VH4005H, VH4010H, V4050, V4100) | Gauge target of 300 mm Hg (green zone). A 375 mm Hg relief valve prevents over-inflation; the gauge shows red with the word “caution” at 375 and pressure releases until it is below 375. | Mesh or clear panel; single patient use; MR Conditional (static field 7 T or less, maximum spatial gradient 19 T/m) | Sun-Med/Novaplus quick reference guide QRG-10015 Rev. 2 |
| Merit Medical Pressure Infusor Bag (PIB500, PIB1000, PIB3000) | Dual pressure valve. Standard setting is factory pre-set for pressurization up to 300 mmHg; a blue button sets the valve to an over-pressure mode labelled as allowing 300-450 mmHg for rapid infusion. | 500 mL, 1000 mL and 3000 mL sizes; non-sterile; pole hanger | Merit Medical product sheet ID031218 |
The practical difference: the Sun-Med/Novaplus documentation describes a single working pressure with a relief ceiling, while the Merit documentation describes a standard limit plus a deliberate higher mode. Both start from 300 mmHg.
Sizes that matter
Merit Medical documents three bag capacities: PIB500 for 500 mL, PIB1000 for 1000 mL and PIB3000 for 3000 mL.
| Model | Capacity | Source |
|---|---|---|
| PIB500 | 500 mL | Merit Medical product sheet |
| PIB1000 | 1000 mL | Merit Medical product sheet |
| PIB3000 | 3000 mL | Merit Medical product sheet |
Features that differ between models
Points that separate one model from another:
- Capacity: cuffs are made for specific fluid bag volumes. Merit Medical sells separate 500 mL, 1000 mL and 3000 mL versions.
- Pressure ceiling: the gauge target and relief or over-pressure behaviour are set by the manufacturer (300 mm Hg target with a 375 mm Hg relief valve for Sun-Med/Novaplus; 300 mmHg standard with a 300-450 mmHg mode for Merit). The instructions for use supplied with the product govern.
- Visibility: a clear panel allows the fluid level to be seen (Sun-Med/Novaplus V4050 and V4100).
- Single patient use and MRI labelling: the Sun-Med/Novaplus models are labelled single patient use and MR Conditional within the limits in the table above.
Always refer to the instructions for use supplied with the specific product. Merit Medical’s product sheet says the same.
Labelling and handling
Sun-Med/Novaplus models are labelled single patient use and disposable, so they are not intended to be reused between patients. Operating instructions differ between manufacturers and are given only in the instructions for use supplied with each model. For related tubing, see the CASRAI guide on arterial line tubing.
Common misunderstandings
- Assuming all models share limits: the Merit dual-valve design permits 300-450 mmHg in its over-pressure mode, while the Sun-Med/Novaplus design vents at 375 mm Hg through a relief valve.
- Treating it as a pump: a pressure infusor applies pressure only; it does not meter flow.
- Treating a single patient use device as reusable: the labelling says otherwise.
- Treating the names as different products: “pressure infusor”, “pressure infuser” and “IV pressure bag” refer to the same class.
FAQ
What is the difference between a pressure infusor and a pressure infuser?
They name the same product class. The FDA regulation uses “pressure infusor for an I.V. bag”; some catalogues spell it “infuser” and many users say “IV pressure bag”.
Is a pressure infusor bag a medical device?
Yes. Under 21 CFR 880.5420 it is a Class I device exempt from 510(k).
What pressure do pressure infusor bags use?
The two documented designs both target 300 mm Hg. Sun-Med/Novaplus adds a 375 mm Hg relief valve; Merit Medical offers a selectable 300-450 mmHg over-pressure mode.
Where can I find related medical supplies?
Browse the infusion supplies category at lac.us.
Sources
- U.S. FDA, 21 CFR 880.5420 Pressure infusor for an I.V. bag, eCFR: https://www.ecfr.gov/current/title-21/section-880.5420 (checked 2026-10-31).
- Sun-Med / Novaplus Pressure Infusion Bag quick reference guide QRG-10015 Rev. 2: https://connect.myairlife.com/resources/QRG-10015_Novaplus%20Pressure%20Infusion_Rev2.pdf (checked 2026-10-31).
- Merit Medical Pressure Infusor Bag product sheet ID031218: https://res.onemed.com/SE/Produktblad/215486.pdf (checked 2026-10-31).
