Device, Warming. Blood And Plasma
The Blood and Plasma Warming Device is a device used to warm refrigerated blood products and intravenous fluids to near body temperature prior to transfusion or infusion, reducing the risk of hypothermia and related complications in patients receiving large volumes of cold blood products. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KZL, regulated under 21 CFR 864.9205, in the Hematology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KZL
- Device Class
- FDA class 2
- Regulation Number
- 864.9205
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K813489 | ROCKING/CIRCULATING CYTO-THERM II 3570 | Mar 04, 1982 | Substantially Equivalent | Cryosan, Inc. |
| K812311 | CIRCULATING CYTO-THERMS | Sep 16, 1981 | Substantially Equivalent | Cryosan, Inc. |
| K800699 | FLO TEM (FLUID WARNER) | May 08, 1980 | Substantially Equivalent | Chroma Products, Inc. |
| K790936 | MODEL 114 TREONIC H150 HAEMOHEATER | Sep 04, 1979 | Substantially Equivalent | Vickers America Medical Corp. |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.