MERCURY MEDICAL CPR BAG EXHALATION FILTER
Device Facts
| Record ID | K954490 |
|---|---|
| Device Name | MERCURY MEDICAL CPR BAG EXHALATION FILTER |
| Applicant | Mercury Medical |
| Product Code | CAH · Anesthesiology |
| Decision Date | Oct 3, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5260 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Device Story
Mercury CPR Bag with Filter; combination of Mercury Medical CPR Resuscitator (K911622) and Medicomp Filter (K851070). Device functions as a bacterial filter for breathing circuits. Used in clinical resuscitation settings to provide ventilation while filtering exhaled/inhaled gases. Output is filtered air delivery to patient. Benefits include reduction of cross-contamination risk during manual ventilation.
Clinical Evidence
Bench testing only; independent laboratory data provided for BFE and VFE.
Technological Characteristics
Resuscitation bag with integrated bacterial/viral filter. Mechanical filtration principle. No software or electronic components.
Regulatory Classification
Identification
A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
Predicate Devices
- Mercury Medical CPR Resuscitator (K911622)
- Medicomp Filter (K851070)
- Intertech/Inspiron Resuscitation Bag Filter (K883693)
- Westmed (K951484)
- Westmed (K953687)
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- K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 · Flexicare Medical Limited. · Dec 7, 2018
- K983919 — EMS MOUTH TO MASK RESUSCITATORS · Engineered Medical Systems · Apr 7, 1999
