BSB · Class II · 21 CFR 864.9205

FDA Product Code BSB: Warmer, Blood, Non-electromagnetic Radiation

Leading manufacturers include Belmont Instrument Corp., Estill Medical Technologies, Inc. and Stihler Electronic GmbH.

14
Total
14
Cleared
96d
Avg days
1976
Since

FDA 510(k) Cleared Warmer, Blood, Non-electromagnetic Radiation Devices (Product Code BSB)

14 devices
1–14 of 14
Cleared Nov 16, 2011
THE BELMONT BUDDY LITE FLUID WARMER
K112639
Belmont Instrument Corp.
Hematology · 65d
Cleared Mar 26, 2009
THE BELMONT BUDDY LITE FLUID WARMER
K090508
Belmont Instrument Corp.
Hematology · 28d
Cleared Oct 19, 2006
BELMONT BUDDY PLUS FLUID WARMER
K062774
Belmont Instrument Corp.
Hematology · 31d
Cleared Oct 13, 2005
BELMONT BUDDY FLUID WARMER
K052547
Belmont Instrument Corp.
Hematology · 27d
Cleared Jul 02, 2003
MICROHEATER
K031478
Belmont Instrument Corp.
Hematology · 51d
Cleared Mar 05, 2002
ASTOFLO
K020060
Nats Corp.
Hematology · 56d
Cleared Jul 26, 2001
MODIFICATION TO THERMAL ANGEL
K012031
Estill Medical Technologies, Inc.
Hematology · 28d
Cleared Sep 03, 1999
PRISMATHERM II, ASTOLINE
K991159
Stihler Electronic GmbH
Hematology · 149d
Cleared Sep 02, 1999
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
K991160
Stihler Electronic GmbH
Hematology · 148d
Cleared Jul 01, 1999
THERMAL ANGEL
K984640
Estill Medical Technologies, Inc.
Hematology · 182d
Cleared Apr 30, 1998
BAIR HUGGER BLOOD/FLUID WARMER
K973741
Augustine Medical, Inc.
Hematology · 211d
Cleared Jun 26, 1996
THERMACYL BLOOD/FLUID WARMER
K953741
Baxter Healthcare Corp
Hematology · 321d
Cleared Feb 14, 1977
BLOOD/FLUID WARMER MODEL DW-1000A
K770232
Gorman Rupp Industries
Hematology · 7d
Cleared Jul 16, 1976
BLOOD WARMER (CODE 4R4305)
K760012
Travenol Laboratories, S.A.
Hematology · 36d

About Product Code BSB - Regulatory Context