FDA-Device2019-05-01Class III
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain ca
GETINGE US SALES LLC
Hazard
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
Sold states
Worldwide distribution - US nationwide in the states of FL, NC and countries of AT, FR, HC, PO.
Affected count
17 boxes (5 catheters per box)
Manufactured in
45 BARBOUR POND DR, N/A, WAYNE, NJ, United States
Products
Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1221-2019Don't want to check this manually?
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