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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: AB5000 Accecssory- 32 FR Sewing Cuff; AB5000 Accessory- 10 mm Arterial Cannula; AB5000 Accessory- 42 FR Sewing Cuff; AB5000 Accessory- Sterile Connector Lubricant
Classification Name: VENTRICULAR (ASSISST) BYPASS
Product Code: DSQ
Device Class: 3
Registered Establishment Name: ISOMEDIX OPERATIONS INC.
Registered Establishment Number: 1220477
Owner/Operator: STERIS Corporation
Owner/Operator Number: 1527821
Establishment Operations: Contract Sterilizer
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