BSB · Warmer, Blood, Non-Electromagnetic Radiation
Hematology · 21 CFR 864.9205 · Class 2
Overview
| Product Code | BSB |
|---|---|
| Device Name | Warmer, Blood, Non-Electromagnetic Radiation |
| Regulation | 21 CFR 864.9205 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.
Classification Rationale
Nonelectromagnetic blood and plasma warming device: Class II (performance standards). Electromagnetic blood and plasma warming device: Class III (premarket approval).
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K112639 | THE BELMONT BUDDY LITE FLUID WARMER | Belmont Instrument Corp. | Nov 16, 2011 | SESE |
| K090508 | THE BELMONT BUDDY LITE FLUID WARMER | Belmont Instrument Corp. | Mar 26, 2009 | SESE |
| K062774 | BELMONT BUDDY PLUS FLUID WARMER | Belmont Instrument Corp. | Oct 19, 2006 | SESE |
| K052547 | BELMONT BUDDY FLUID WARMER | Belmont Instrument Corp. | Oct 13, 2005 | SESE |
| K031478 | MICROHEATER | Belmont Instrument Corp. | Jul 2, 2003 | SESE |
| K020060 | ASTOFLO | Nats Corp. | Mar 5, 2002 | SESE |
| K012031 | MODIFICATION TO THERMAL ANGEL | Estill Medical Technologies, Inc. | Jul 26, 2001 | SESE |
| K991159 | PRISMATHERM II, ASTOLINE | Stihler Electronic GmbH | Sep 3, 1999 | SESE |
| K991160 | ASTOTHERM PLUS, ASTOTUBES, ASTOLINE | Stihler Electronic GmbH | Sep 2, 1999 | SESE |
| K984640 | THERMAL ANGEL | Estill Medical Technologies, Inc. | Jul 1, 1999 | SESE |
| K973741 | BAIR HUGGER BLOOD/FLUID WARMER | Augustine Medical, Inc. | Apr 30, 1998 | SESE |
| K953741 | THERMACYL BLOOD/FLUID WARMER | Baxter Healthcare Corp | Jun 26, 1996 | SESE |
| K770232 | BLOOD/FLUID WARMER MODEL DW-1000A | Gorman Rupp Industries | Feb 14, 1977 | SESE |
| K760012 | BLOOD WARMER (CODE 4R4305) | Travenol Laboratories, S.A. | Jul 16, 1976 | SESE |
Top Applicants
- Belmont Instrument Corp. — 5 clearances
- Estill Medical Technologies, Inc. — 2 clearances
- Stihler Electronic GmbH — 2 clearances
- Augustine Medical, Inc. — 1 clearance
- Baxter Healthcare Corp — 1 clearance
