Arctic Blast Intravenous Fluid Chiller
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K080899 FDA 510(k)
- FDA Product Code
- NCX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5900 FDA 510(k)
- Regulation Number
- 870.5900 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Arctic Blast Intravenous Fluid Chiller is a device designed to cool sterile solutions during intravenous administration, as indicated for reducing body temperature when clinically necessary. It is classified as a Class II medical device under the FDA's regulation number 870.5900 and is intended for use in cardiovascular procedures.
The device consists of a heat exchanger assembly and an adsorption cooling module. It is supplied as a single-use system and requires connection to a liter bag of sterile fluid and a standard commercially-available outlet. The device is not specified as MRI-safe and should be stored according to manufacturer guidelines.
Frequently asked questions
What is the Arctic Blast Intravenous Fluid Chiller used for?
It is designed to cool sterile solutions during intravenous administration to reduce body temperature when clinically necessary, often used in cardiovascular procedures.
How is the Arctic Blast Intravenous Fluid Chiller supplied?
It is supplied as a single-use system that requires connection to a liter bag of sterile fluid and a standard commercially-available outlet.
What are the key components of the device?
The device consists of a heat exchanger assembly and an adsorption cooling module.
Is the Arctic Blast Intravenous Fluid Chiller MRI-safe?
No, the device is not specified as MRI-safe and should be stored according to manufacturer guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FDA Browser - Cleared 510 (K) - ARCTIC BLAST INTRAVENOUS FLUID CHILLER ..., Arctic Blast Intravenous Fluid Chiller 510 (k) FDA Premarket ..., PDF AUG 7 20DD - accessdata.fda.gov, Medivance, Inc. FDA 510 (k) Cardiovascular Products - Latest 2025
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080899 | Class II | Active |
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Manufacturer
- Manufacturer
- Medivance, Inc.
Sources (1)
- FDA 510(k) K080899 24 fields · synced Sep 26, 2026