I.V. BAG ADDISEAL

K832247 · Baxa Corp., Sub. of Cook Group, Inc. · KPE · Jul 26, 1983 · General Hospital

Device Facts

• Record ID: K832247
• Device Name: I.V. BAG ADDISEAL
• Applicant: Baxa Corp., Sub. of Cook Group, Inc.
• Product Code: KPE · General Hospital
• Decision Date: Jul 26, 1983
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5025
• Device Class: Class 2

Regulatory Classification

Identification

An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.