FDA-Device2016-08-17Class III
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
C.R. Bard, Inc.
Hazard
An internal review of an available product found that the Information For Use only contained English and Japanese languages when a CE-marked 23 language version was expected.
Sold states
US Distribution to the states of : CA, FL, GA, IL, IN, MI, MN, MO, NY, OR, PA, TX, WA, and Internationally to Germany, Italy and Switzerland
Affected count
64
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2345-2016Don't want to check this manually?
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