Blood Transfusion Kit
The Blood Transfusion Kit (product code POQ) is a Class 2 general hospital convenience kit established under the FDA's Convenience Kits Interim Regulatory Guidance, regulated under 880.5440. Under enforcement discretion guidelines, this type of kit does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- POQ
- 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 www.Fda.Gov/cdrh/ode/convkit.Html. 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 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.