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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Portex BLUselect Suctionaid Tracheostomy Tube; Portex BLUselect Tracheostomy Inner Cannula; Portex BLUselect Tracheostomy Tube
Classification Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
Product Code: BTO
Device Class: 2
Regulation Number: 868.5800
Medical Specialty: Anesthesiology
Registered Establishment Name: ICU Medical Healthcare Manufacturing S.A. de C.V.
Registered Establishment Number: 9616567
Premarket Submission Number: K173384
Owner/Operator: ICU Medical, Inc.
Owner/Operator Number: 8020727
Establishment Operations: Manufacturer
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