Product code BSB
- Device name
- Warmer, Blood, Non-Electromagnetic Radiation
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.9205
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K112639 | THE BELMONT BUDDY LITE FLUID WARMER | Belmont Instrument Corp. | 2011-11-16 |
| K090508 | THE BELMONT BUDDY LITE FLUID WARMER | Belmont Instrument Corp. | 2009-03-26 |
| K062774 | BELMONT BUDDY PLUS FLUID WARMER | Belmont Instrument Corp. | 2006-10-19 |
| K052547 | BELMONT BUDDY FLUID WARMER | Belmont Instrument Corp. | 2005-10-13 |
| K031478 | MICROHEATER | Belmont Instrument Corp. | 2003-07-02 |
| K020060 | ASTOFLO | Nats Corp. | 2002-03-05 |
| K012031 | MODIFICATION TO THERMAL ANGEL | Estill Medical Technologies, Inc. | 2001-07-26 |
| K991159 | PRISMATHERM II, ASTOLINE | Stihler Electronic GmbH | 1999-09-03 |
| K991160 | ASTOTHERM PLUS, ASTOTUBES, ASTOLINE | Stihler Electronic GmbH | 1999-09-02 |
| K984640 | THERMAL ANGEL | Estill Medical Technologies, Inc. | 1999-07-01 |
| K973741 | BAIR HUGGER BLOOD/FLUID WARMER | Augustine Medical, Inc. | 1998-04-30 |
| K953741 | THERMACYL BLOOD/FLUID WARMER | Baxter Healthcare Corp | 1996-06-26 |
| K770232 | BLOOD/FLUID WARMER MODEL DW-1000A | Gorman Rupp Industries | 1977-02-14 |
Related GUDID Devices#
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| 05745000140039 | °M Warmer System - Power Pack | Mequ A/S | 2024-10-09 |
| 05700002076816 | °M Warmer System - °M Warmer | Mequ A/S | 2024-10-09 |
| 04260114141440 | ASTOTUBE® | Stihler Electronic GmbH | 2024-08-16 |
| 04260114141433 | ASTOTUBE® | Stihler Electronic GmbH | 2024-08-16 |
| 00861816000345 | TA-UPC Ultra Power Cable 3' | Estill Medical Technologies, Inc. | 2024-03-28 |
| 00861816000307 | Thermal Angel | Estill Medical Technologies, Inc. | 2023-12-31 |
| 27290016740169 | QinFlow Warrior Lite set with 2 Lite Extra Power Battery | QUALITY IN FLOW LTD | 2023-01-05 |
| 00842209125784 | NAR | NORTH AMERICAN RESCUE, LLC | 2022-12-22 |
| 00842209125159 | NAR | NORTH AMERICAN RESCUE, LLC | 2022-10-31 |
| 00707387808990 | 3M™ Ranger™ | 3M COMPANY | 2021-11-23 |
| 10707387805002 | 3M™ Ranger™ | 3M COMPANY | 2021-06-21 |
| 10707387792678 | 3M™ Ranger™ | 3M COMPANY | 2021-06-21 |
| 10707387792685 | 3M™ Ranger™ | 3M COMPANY | 2021-06-21 |
| 10707387792708 | 3M™ Ranger™ | 3M COMPANY | 2021-06-21 |
| 10707387792715 | 3M™ Ranger™ | 3M COMPANY | 2021-06-21 |
| 10707387792647 | 3M™ Ranger™ | 3M COMPANY | 2021-06-21 |
| 00707387803414 | 3M™ Ranger™ | 3M COMPANY | 2021-03-10 |
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| 00868058000416 | Life Warmer Quantum Thermal Transfusion Set for Blood and Blood Products (TTS-B) | NORTH AMERICAN RESCUE, LLC | 2019-09-03 |
| 00868058000423 | Life Warmer Quantum Battery | NORTH AMERICAN RESCUE, LLC | 2019-09-03 |
| 00868058000430 | Life Warmer Quantum Charger | NORTH AMERICAN RESCUE, LLC | 2019-09-03 |
| 00868058000447 | Life Warmer Quantum Controller | NORTH AMERICAN RESCUE, LLC | 2019-09-03 |
| 00868058000485 | Life Warmer Quantum Blood and Fluid Warming System | NORTH AMERICAN RESCUE, LLC | 2019-09-03 |
| 00868058000409 | Life Warmer Quantum Thermal Infusion Set (TIS) | NORTH AMERICAN RESCUE, LLC | 2019-09-03 |
| 04260114140610 | ASTOTUBE® | Stihler Electronic GmbH | 2016-09-07 |
| 04260114140627 | ASTOTUBE® | Stihler Electronic GmbH | 2016-09-07 |
| 04260114140634 | ASTOTUBE® | Stihler Electronic GmbH | 2016-09-07 |
| 04260114140641 | ASTOTUBE® | Stihler Electronic GmbH | 2016-08-11 |