Blood Administration Kit
The Blood Administration Kit is a general hospital convenience kit containing the tubing sets, filters, and accessories needed to administer blood or blood products to a patient through an intravenous route, ensuring safe and controlled transfusion delivery. Product code PWO is established as a convenience kit under FDA's 1997 Convenience Kits Interim Regulatory Guidance and is under enforcement discretion, not requiring a 510(k) if all guidance criteria are met. Under regulation 21 CFR 880.5440, it is a Class II device subject to general and special controls. It falls under the General Hospital medical specialty and is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PWO
- Device Class
- FDA class 2
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.