FDA-Device2020-11-11Class II
Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).
3M Company - Health Care Business
Hazard
Corrosion could cause performance failures in the product.
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada).
Affected count
156,600 units
Manufactured in
3m Center 2510 Conway Ave, Bldg 275-5W-06, Saint Paul, MN, United States
Products
Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0420-2021Don't want to check this manually?
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