Warmer, Blood, Non-Electromagnetic Radiation

FDA product code BSB · Class II (moderate risk) · 21 CFR 864.9205 · Hematology

14510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K112639The Belmont Buddy Lite Fluid WarmerBSB · Special Belmont Instrument Corp.11/16/2011SE
K090508The Belmont Buddy Lite Fluid WarmerBSB · Special Belmont Instrument Corp.03/26/2009SE
K062774Belmont Buddy Plus Fluid WarmerBSB · Special Belmont Instrument Corp.10/19/2006SE
K052547Belmont Buddy Fluid WarmerBSB · Special Belmont Instrument Corp.10/13/2005SE
K031478MicroheaterBSB · Traditional Belmont Instrument Corp.07/02/2003SE
K020060AstofloBSB · Abbreviated Nats Corp.03/05/2002SE
K012031Modification to Thermal AngelBSB · Special Estill Medical Technologies, Inc.07/26/2001SE
K991159Prismatherm II, AstolineBSB · Abbreviated Stihler Electronic GmbH09/03/1999SE
K991160Astotherm Plus, Astotubes, AstolineBSB · Abbreviated Stihler Electronic GmbH09/02/1999SE
K984640Thermal AngelBSB · Traditional Estill Medical Technologies, Inc.07/01/1999SE
K973741Bair Hugger Blood/Fluid WarmerBSB · Traditional Augustine Medical, Inc.04/30/1998SE
K953741Thermacyl Blood/Fluid WarmerBSB · Traditional Baxter Healthcare Corp06/26/1996SE
K770232Blood/Fluid Warmer Model DW-1000ABSB · Traditional Gorman Rupp Industries02/14/1977SE
K760012Blood Warmer (Code 4R4305)BSB · Traditional Travenol Laboratories, S.A.07/16/1976SE

Recalls

RecallProductFirmInitiated
Z-2483-2025 Class I3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet… 3M Company04/10/2025Open, Classified
Z-0101-2015 Class IIUltra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a…Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity… Estill Medical Technologies, Inc07/25/2014Terminated