Life Warmer Quantum Controller
- Primary DI
- 00868058000447
- Brand
- Life Warmer Quantum Controller
- Company
- NORTH AMERICAN RESCUE, LLC
- Model
- 63-5901
- Catalog number
- 35-0003
- Device description
- The Life Warmer Quantum Controller is the command center of the Quantum Blood and Fluid Warming System. It contains the microprocessor and control algorithm that continually assesses temperature input from tubing thermistors and regulates the energy provided to the tubing heating elements in the proximal and/or distal segments to reach and maintain temperature between 100.4°F (38°+/- 2°C) at patient delivery. The Controller receives power when connected to the Battery and modulates the energy flow to the TIS/TTS-B. The Quantum Controller has two connections, one for the battery and one for the Thermal Tubing of choice. The connection to the battery is an omni-directional plug for ease of insertion and the connection is safe and secure. The connection to the TIS or TTS-B is bi-directional and simple to execute- it’s plug and play.The Controller has LED lights on the shoulder of the device to inform the user about the output temperature and flow of the fluid. It will visually alert the care provider to the status of the system.The Controller is reusable and comes fitted with a Jacket that permits the mating (connection) of the TIS or TTS-B Life Warmer tubing circuit connector to the connector slot on the Controller.
- Published
- 2019-09-03
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
Product Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K181775 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00868058000447 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00868058000447 | 00868058000447 | 868058000447 | 0868058000447 |
GMDN Terms#
| Term | Definition |
|---|---|
| Conduction blood/fluid warmer | A mains electricity (AC-powered) device, which may include rechargeable batteries, designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 832426782
- Device count
- 1
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- No natural rubber latex
- true
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| 00842209140466 | NAR | 85-5245 | 85-5245 | 2026-10-14 |
| 00842209140473 | NAR | 80-0494A | 80-0494A | 2026-10-14 |
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| 00842209140510 | NAR | 80-1157A | 80-1157A | 2026-10-14 |
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| 00842209140534 | NAR | 82-0076A | 82-0076A | 2026-10-14 |
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| B286SWC243074MBST1 | Single Chamber Warming Cabinet | M.A.C. MEDICAL INC. | LGZ | 2026-09-30 |
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| B286DWC243074TTS4B1 | Dual Chamber Warming Cabinet | M.A.C. MEDICAL INC. | LGZ | 2026-08-27 |
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| B286SWC151822LHNB1 | Single CHAMBER WARMING CABINET | M.A.C. MEDICAL INC. | LGZ | 2026-08-21 |
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| B286DWC183074EGMB220C1 | Dual Chamber Warming Cabinet | M.A.C. MEDICAL INC. | LGZ | 2026-08-18 |
| B286DWC183074T4BAVT1 | Dual Chamber Warming Cabinet | M.A.C. MEDICAL INC. | LGZ | 2026-08-18 |
| B286DWC183074T4BR21 | Dual Chamber Warming Cabinet | M.A.C. MEDICAL INC. | LGZ | 2026-08-18 |
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| B286DWC242464T4B1 | Dual Chamber Warming Cabinet | M.A.C. MEDICAL INC. | LGZ | 2026-08-18 |
| B286DWC242464TMB1 | Dual Chamber Warming Cabinet | M.A.C. MEDICAL INC. | LGZ | 2026-08-18 |
| B286DWC242474EGMB220C1 | Dual Chamber Warming Cabinet | M.A.C. MEDICAL INC. | LGZ | 2026-08-18 |
| B286DWC242474TG4BR21 | Dual Chamber Warming Cabinet | M.A.C. MEDICAL INC. | LGZ | 2026-08-18 |
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