FDA-Device2019-09-11Class II
Norm-O-Temp model 111Z
Cincinnati Sub-Zero Products LLC, a Gentherm Company
Hazard
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
Sold states
Ship-To State AL AR AZ CA CO CT DC DE FL GA HI IL IN KS KY LA MA MD ME MI MN MO NC ND NE NH NJ NM NY OH OK PA RI SC TN TW TX UT VA WA WI WV WY Ship-To Country United States Taiwan Egypt United Arab Emirates Israel Pakistan Turkey Colombia Thailand Kuwait United Kingdom Mexico Netherlands Canada Ecuador South Korea Germany Georgia China Panama Japan Malaysia Hong Kong Austria Chile Mongolia Morocco Australia Indonesia Venezuela Singapore
Affected count
674
Manufactured in
12011 Mosteller Rd, N/A, Cincinnati, OH, United States
Products
Norm-O-Temp model 111Z
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2355-2019Don't want to check this manually?
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