FDA-Device2019-07-24Class III
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Teleflex Medical
Hazard
The device labels are not UDI compliant. The missing UDI compliance information on the labelling is not likely to affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
Sold states
Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.
Affected count
105426 US eaches
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1974-2019Don't want to check this manually?
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