FDA-Device2016-11-09Class II
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Unomedical As
Hazard
Tubing detachment
Sold states
Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
Affected count
664,000 units
Manufactured in
Aholmvej 1 3 Osted, Roskilde, Denmark
Products
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0356-2017Don't want to check this manually?
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