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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Detachable holder and preattached; Mixject Dispensing Pin w/Detachable; Mixject Dispensing Pin with; MIXJECT Mixject Dispensing Pin; Needle Mixject; Preattached Vial Adaptor; Vial Adaptor; Vial Connector; Vial Holder
Classification Name: SET, I.V. FLUID TRANSFER
Product Code: LHI
Device Class: 2
Regulation Number: 880.5440
Medical Specialty: General Hospital
Registered Establishment Name: 3BY LTD.
Registered Establishment Number: 3004201393
Premarket Submission Number: K963583
Owner/Operator: 3BY Ltd.
Owner/Operator Number: 9050049
Establishment Operations: Contract Manufacturer
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