Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) → BRZ — Set, Blood Transfusion # BRZ · Set, Blood Transfusion _General Hospital · 21 CFR 880.5440 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ ## Overview - **Product Code:** BRZ - **Device Name:** Set, Blood Transfusion - **Regulation:** [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container. ## Classification Rationale Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9. ## Special Controls *Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9. ## Recent Cleared Devices (20 of 30) Showing 20 most recent of 30 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K220558](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K220558.md) | Blood Administration Sets | Baxter Healthcare Corporation | Nov 17, 2022 | SESE | | [K210335](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K210335.md) | Blood Administration Set | Baxter Healthcare Corporation | Jun 10, 2021 | SESE | | [K132905](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K132905.md) | 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER | Arteriocyte Medical Systems, Inc. | Oct 4, 2013 | SESE | | [K083349](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K083349.md) | BLOOD TRANSFUSION SET | Shan Dong Wei Gao Group Medical Polymer Products | Apr 10, 2009 | SESE | | [K073339](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K073339.md) | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR | Fenwal, Inc. | Mar 3, 2008 | SESE | | [K041496](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K041496.md) | PENTATRASFU BLOOD TRANSFUSION SETS | Pentaferte S.P.A | Jun 30, 2005 | SESE | | [K050805](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K050805.md) | 30 ML OR 60 ML PEDI-SYRINGE FILTER | Blood Products Specialties, LLC | Jun 20, 2005 | SESE | | [K050115](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K050115.md) | BLOOD HAND PUMP ADMINISTRATION SET | Cardinal Health, Alaris Products | Apr 1, 2005 | SESE | | [K023039](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K023039.md) | BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 | Tuta Healthcare Pty Limited | Nov 7, 2002 | SESE | | [K000685](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K000685.md) | CHARTER MEDICAL NEONATAL SYRINGE SET | Charter Medical, Ltd. | Aug 15, 2000 | SESE | | [K993120](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K993120.md) | MODIFIED BLOOD RECIPIENT SET | Baxter Healthcare Corp | Nov 17, 1999 | SESE | | [K972843](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K972843.md) | PROTOS BLOOD TRANSFUSION SET | Globe Ent., Inc. | Dec 16, 1997 | SESE | | [K940074](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K940074.md) | Y-TYPE BLOOD ADMINISTRATION SET | Puritas Health Care, Inc. | Apr 21, 1994 | SESE | | [K940055](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K940055.md) | MULTISET | Puritas Health Care, Inc. | Apr 15, 1994 | SESE | | [K921595](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K921595.md) | Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2 | Haemotronic, Inc. | Dec 24, 1992 | SESE | | [K920788](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K920788.md) | BLOOD ADMINISTRATION SET | Douglas Medical Products Corp. | Jun 4, 1992 | SESE | | [K880174](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K880174.md) | JMS TRANSFUSION SET | Jms Co., Ltd. | Feb 16, 1988 | SESE | | [K871908](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K871908.md) | IV ADMINISTRATION SET | Travenol Laboratories, S.A. | Jul 27, 1987 | SESE | | [K864441](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K864441.md) | CHURCHILL BLOOD ADMINISTRATION SET | Churchill Corp. | Jan 20, 1987 | SESE | | [K861523](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ/K861523.md) | STANDARD BLOOD TRANSFUSION FILTER SET (CODE 1025) | Jufrey Multimed Corp. | May 27, 1986 | SESE | ## Top Applicants - Baxter Healthcare Corporation — 2 clearances - Puritas Health Care, Inc. — 2 clearances - The Boston Medical Group — 2 clearances - Alpha Therapeutic Corp. — 1 clearance - Amkor Trading Co. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/BRZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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