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Devices
Decathlon Funnel Tip
Model / Serial
All lot codes
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide distribution - Nationwide, Government. Foreign: Canada, France.
Product Description
28CM DECATHLON FUNNEL TIP STD KIT || Model: DF23SH28 || DECATHLON FUNNEL TIP || 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and || apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, || 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
Manufacturer
Spire Biomedical, Inc.
2 Events
Recall of Decathlon Funnel Tip
Recall of Decathlon Funnel Tip
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Manufacturer
Spire Biomedical, Inc.
Manufacturer Address
Spire Biomedical, Inc., One Patriots Park, Bedford MA 01730-2343
Manufacturer Parent Company (2017)
Spire Corporation
Source
USFDA
Language
English
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