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General product information only, not medical advice and not a procedure guide. Device selection and use belong to trained clinicians following the manufacturer’s instructions for use (IFU) and local protocol.
Short answer
An infant BVM is a bag-valve-mask resuscitator sold in an infant size. In one manufacturer’s IFU (Laerdal’s The BAG II) the infant model is labelled for 2.5-12 kg, delivers a nominal 180 ml with one-hand compression, and has a pressure-limiting valve at about 35 ± 5 cmH2O. Those figures belong to that brand; other infant units list different volumes.
Definition and scope
A bag-valve-mask (BVM), also called a manual resuscitator, is a hand-operated bag with a patient valve and a face mask. FDA’s AccessGUDID database files the products cited here under product code BTM, “Ventilator, Emergency, Manual (Resuscitator)”, for both the child and the infant record. The size is therefore not a separate regulatory category: it comes from the manufacturer’s labelling. For the general device, see what a bag-valve-mask is.
How it works and how it is used in practice
Pop-off valve and override
In the Laerdal IFU, infant and child units carry a pressure-limiting device that “opens at a pressure of approx. 35 ± 5 cmH2O. However, an abrupt, high-volume manual breath may cause the unit to exceed this level.” The same IFU states the valve can be overridden or locked using a push-twist feature. The AirLife record likewise names a pressure-limiting valve with lock. For how these valves are built and what variants exist, see the Ambu bag pop-off valve guide; for the related add-on, see PEEP valves for bag-valve-masks.
Single-patient use and latex labelling
The Laerdal IFU states: “The resuscitator is for single patient use only. Do not reuse. Do not sterilize.” It also states the product is not made with natural rubber latex. FDA AccessGUDID shows the single-use flag as “Yes” for the Laerdal child record (device identifier 07045432067989) and the AirLife infant record, and the AirLife record carries a “not made with natural rubber latex” label. The Laerdal child record does not carry the “not made with natural rubber latex” label, so latex status comes from the label or IFU of the unit rather than being assumed.
Types or related concepts
Infant, child and adult models in one manufacturer’s labelling
The table below is taken only from the Laerdal The BAG II directions for use, “Performance and Specifications” table. The table footnote states the products were tested according to ISO 10651-4:2002 and ASTM F920-93. Treat it as an example of how specifications are stated, not as a universal size chart.
| Model | Labelled patient weight | Delivered tidal volume, one-hand | Bag, maximum measured volume | Pressure relief valve |
|---|---|---|---|---|
| Adult | > 20 kg | 830 ml | 1650 ml | Not provided |
| Child | 10-20 kg | 330 ml (nominal) | 500 ml | 35 ± 5 cmH2O |
| Infant | 2.5-12 kg | 180 ml (nominal) | 230 ml | 35 ± 5 cmH2O |
The IFU warns: “The wrong size can result in inadequate or excessive air pressure being delivered to the patient.” Its catalogue also pairs each model with a Laerdal mask number (infant with mask #1; child with #3 or #2; adult with #5 or #4); those mask numbers are that company’s own naming.
Figures differ between brands
FDA’s AccessGUDID record for an AirLife infant manual resuscitator (device identifier 10885403220784) lists a total volume of 280 ml and describes the kit as an infant manual resuscitator with 40-inch oxygen reservoir tubing, an infant mask, a pressure-limiting valve with lock and 7-foot oxygen tubing. Compare that with the 230 ml bag volume in the table above: two infant units, two different volumes, and the figures are not necessarily measured the same way. This is why the IFU of the exact unit in hand is the reference.
Where it matters for labs, clinics or supply decisions
Every item below is a field that appears in the IFU or GUDID records cited on this page. It is a record-keeping aid, not a rule for choosing a device.
- Labelled weight band: copy it from the IFU. GUDID can show “No Device Sizes”, so the band may not be in the database.
- Stated volumes: note whether the figure is delivered tidal volume, bag volume or total volume, since manufacturers report different ones.
- Pressure-limiting valve: present or absent, its stated opening pressure, and whether it can be locked or overridden.
- Single-patient use: the IFU statement and the GUDID single-use flag.
- Latex labelling: the label or GUDID statement.
- What is in the pack: reservoir and tubing, and which mask the model is supplied with.
- Standards named: for example ISO 10651-4, as printed in the IFU.
For wider clinic stocking context, see the pediatric clinic supply checklist, and for airway adjunct sizing the oral airway sizes guide.
Common misunderstandings
- “Infant BVM sizes are standard.” The Laerdal infant bag is 230 ml and the AirLife infant total volume is 280 ml; the labelled weight band is the manufacturer’s.
- “The pop-off valve makes over-pressure impossible.” The Laerdal IFU says an abrupt, high-volume breath can exceed the valve’s level.
- “The size is in the FDA classification.” Product code BTM covers the category; the GUDID record for the Laerdal child unit lists no device sizes.
- “A resuscitator can be sterilised and reused.” The Laerdal IFU says single patient use, do not sterilise.
FAQ
What are bag valve mask sizes?
Manufacturers typically make adult, child and infant models. In Laerdal’s IFU these are labelled > 20 kg, 10-20 kg and 2.5-12 kg, with masks numbered separately. Other brands state their own bands and volumes, so the IFU of the unit in question is the reference.
What is a pediatric bag valve mask?
It is a bag-valve-mask built in a smaller size for children or infants, with a smaller bag and mask and, in the Laerdal and AirLife examples above, a pressure-limiting valve. Brands may use “pediatric” for the child model or for both child and infant models, so the weight band on the label is what defines the unit.
Is an infant BVM reusable?
That depends on the product. The Laerdal The BAG II is single patient use only per its IFU, and FDA GUDID lists single-use for the records cited here. A reusable model would state its own reprocessing instructions.
Sources
- Laerdal Medical, “The BAG II” directions for use (PDF), https://cdn.laerdal.com/downloads/f4968/the_bag_ii, checked 2026-10-30.
- FDA AccessGUDID, AirLife infant manual resuscitator, https://accessgudid.nlm.nih.gov/devices/10885403220784, checked 2026-10-30.
- FDA AccessGUDID, Laerdal BAG II child resuscitator, https://accessgudid.nlm.nih.gov/devices/07045432067989, checked 2026-10-30.
