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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: SEDBBLG SEDASYS BITE BLOCK, LARGE; SEDBBSM SEDASYS BITE BLOCK, SMALL; SEDCAN01 SEDASYS ORAL/NASAL CANNULA; SEDCAS01 SEDASYS DRUG DELIVERY CASSETTE
Classification Name: COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
Product Code: PDR
Device Class: 3
Registered Establishment Name: AVAILMED S.A. DE C.V. (MEXICO)
Registered Establishment Number: 8030670
Owner/Operator: Flextronics International Inc.
Owner/Operator Number: 9006592
Establishment Operations: Contract Manufacturer
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