Warmer, Blood, Non-Electromagnetic Radiation
The Warmer, Blood, Non-Electromagnetic Radiation is a device that heats blood or blood products before infusion using methods other than electromagnetic radiation, such as conductive or convective heating, to reduce the risk of transfusion-related hypothermia. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BSB, regulated under 21 CFR 864.9205 in the Hematology specialty.
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Basic Information
- Product Code
- BSB
- 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 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K112639 | THE BELMONT BUDDY LITE FLUID WARMER | Nov 16, 2011 | Substantially Equivalent | Belmont Instrument Corp. |
| K090508 | THE BELMONT BUDDY LITE FLUID WARMER | Mar 26, 2009 | Substantially Equivalent | Belmont Instrument Corp. |
| K062774 | BELMONT BUDDY PLUS FLUID WARMER | Oct 19, 2006 | Substantially Equivalent | Belmont Instrument Corp. |
| K052547 | BELMONT BUDDY FLUID WARMER | Oct 13, 2005 | Substantially Equivalent | Belmont Instrument Corp. |
| K031478 | MICROHEATER | Jul 02, 2003 | Substantially Equivalent | Belmont Instrument Corp. |
| K020060 | ASTOFLO | Mar 05, 2002 | Substantially Equivalent | Nats Corp. |
| K012031 | MODIFICATION TO THERMAL ANGEL | Jul 26, 2001 | Substantially Equivalent | Estill Medical Technologies, Inc. |
| K991159 | PRISMATHERM II, ASTOLINE | Sep 03, 1999 | Substantially Equivalent | Stihler Electronic GmbH |
| K991160 | ASTOTHERM PLUS, ASTOTUBES, ASTOLINE | Sep 02, 1999 | Substantially Equivalent | Stihler Electronic GmbH |
| K984640 | THERMAL ANGEL | Jul 01, 1999 | Substantially Equivalent | Estill Medical Technologies, Inc. |
| K973741 | BAIR HUGGER BLOOD/FLUID WARMER | Apr 30, 1998 | Substantially Equivalent | Augustine Medical, Inc. |
| K953741 | THERMACYL BLOOD/FLUID WARMER | Jun 26, 1996 | Substantially Equivalent | Baxter Healthcare Corp |
| K770232 | BLOOD/FLUID WARMER MODEL DW-1000A | Feb 14, 1977 | Substantially Equivalent | Gorman Rupp Industries |
| K760012 | BLOOD WARMER (CODE 4R4305) | Jul 16, 1976 | Substantially Equivalent | Travenol Laboratories, S.A. |
FEI Numbers
This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.