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BSB — Warmer, Blood, Non-Electromagnetic Radiation Class II

FDA Device Classification

FDA product code BSB covers "Warmer, Blood, Non-Electromagnetic Radiation", a Class II medical device regulated under 21 CFR 864.9205. Submissions are reviewed by the Hematology panel. At least 14 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
BSB
Device Class
Class II
Regulation Number
864.9205
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K112639belmont instrumentTHE BELMONT BUDDY LITE FLUID WARMERNovember 16, 2011
K090508belmont instrumentTHE BELMONT BUDDY LITE FLUID WARMERMarch 26, 2009
K062774belmont instrumentBELMONT BUDDY PLUS FLUID WARMEROctober 19, 2006
K052547belmont instrumentBELMONT BUDDY FLUID WARMEROctober 13, 2005
K031478belmont instrumentMICROHEATERJuly 2, 2003
K020060natsASTOFLOMarch 5, 2002
K012031estill medical technologiesMODIFICATION TO THERMAL ANGELJuly 26, 2001
K991159stihler electronicPRISMATHERM II, ASTOLINESeptember 3, 1999
K991160stihler electronicASTOTHERM PLUS, ASTOTUBES, ASTOLINESeptember 2, 1999
K984640estill medical technologiesTHERMAL ANGELJuly 1, 1999
K973741augustine medicalBAIR HUGGER BLOOD/FLUID WARMERApril 30, 1998
K953741baxter healthcareTHERMACYL BLOOD/FLUID WARMERJune 26, 1996
K770232gorman rupp industriesBLOOD/FLUID WARMER MODEL DW-1000AFebruary 14, 1977
K760012travenol laboratoriesBLOOD WARMER (CODE 4R4305)July 16, 1976

FDA data resources