Devices

Southmedic Oxygen Masks with EtCO2 sampling line part number OM21258, 25 masks per case.

Model / Serial
Part No. (Lot No.); OM-2125-8 (W40056, W40161, W40162, W40317, W40556, W40645, W40668); OK-2125-8 (W37602, W37898, W39852, W40051, W40863); OK-2125-8SLM (W36957, W39164, W39695, W41454); OM-2125-14 (W36512, W38338); OM-2125-14SLM (W35876, W39251, W40873); OM-2125-8 (W36432, W36433, W37099, W37605, W37741, W37742, W37743, W37998, W38477, W38641, W39023, W39850, W40056, W40161, W40162, W40317, W40556, W40645, W40668); OM-2125-8SLM (W36956, W37342, W37488, W37899, W38700, W38905, W39252, W39545, W39546); OM-2325-8(W38340); OP-2125-14 (W37273, W39697); OP-2125-8 (W37031, W38005, W38190, W39027, W39851); OP-2125-8SLM (W37901, W38692, W39253, W41447)
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution to the state of California, and Internationally to Canada and Sweden
Product Description
Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. || Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
Manufacturer
Southmedic, Inc.
1 Event
- Recall of Southmedic Oxygen Masks with EtCO2 sampling line part number OM21258, 25 masks per case.

Manufacturer

Southmedic, Inc.

Manufacturer Address
Southmedic, Inc., 50 Alliance Blvd, Barrie Canada
Manufacturer Parent Company (2017)
Southmedic, Inc.
Source
USFDA

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