Blood Transfusion Set
by Shan Dong Wei Gao Group Medical Polymer Products
510(k) K083349
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083349 | Date10 Apr 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BRZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Blood Transfusion Set is a sterile, single-use medical device designed for the administration of blood or blood components to patients. It facilitates the controlled transfer of fluids from a blood bag or container into a patient’s venous system, ensuring compatibility with intravenous administration protocols and minimizing contamination risks.
This device is supplied as a sterile, disposable item intended for use in general hospital settings. It is classified under FDA regulation 880.5440 and has received a 510(k) clearance as substantially equivalent to a predicate device. The set is packaged individually and must be used once before disposal, adhering to standard infection control practices. No MRI safety information is specified, and sizes or additional technical specifications are not detailed in the provided data.
Other devices from Shan Dong Wei Gao Group Medical Polymer Products
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of this blood transfusion set and where is it typically used?
This blood transfusion set is designed to safely administer blood or blood components to patients through intravenous methods. It is intended for use in general hospital settings, ensuring controlled fluid transfer while minimizing contamination risks during transfusions.
Is this device reusable or single-use, and how should it be handled to maintain sterility?
The blood transfusion set is a sterile, single-use device, meaning it must be discarded after one use to prevent infection. It is packaged individually and adheres to standard infection control practices, so it should remain unopened until immediately before use and handled with sterile technique.
Does this device come in multiple sizes or configurations, and if not, what should buyers expect?
The provided data does not specify any details about sizes, configurations, or technical specifications for this blood transfusion set. Buyers should confirm with the manufacturer (Shan Dong Wei Gao Group Medical Polymer Products) regarding specific models or variations if those are required for their clinical needs.
How is this device regulated, and what does the FDA clearance indicate about its safety and equivalence?
This blood transfusion set has received FDA 510(k) clearance under regulation 880.5440, with a decision classification of *substantially equivalent* to a predicate device. This means the FDA has determined it meets the same performance standards as an existing approved device, ensuring it is safe and effective for its intended use in general hospital settings.
Are there any special storage requirements for this device before use?
While the data does not specify exact storage conditions, as a sterile, single-use medical device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s instructions for optimal shelf life and sterility preservation.