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Sign in to claim this brandK2 Scientific, LLC
US
Last updated May 27, 2026
What K2 Scientific, LLC makes
K2 Scientific, LLC designs and manufactures blood refrigerators, blood refrigerator/freezer units, and blood plasma freezers. These devices are engineered to store and preserve blood components and plasma at controlled temperatures, ensuring safety and viability for medical use.
The company’s products fall under FDA Class II regulatory classification and are listed in the FDA’s Unique Device Identifier (UDI) database. These devices are intended for use within the United States, adhering to applicable medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does K2 Scientific, LLC manufacture?
K2 Scientific, LLC specializes in blood storage devices, including blood refrigerators, blood refrigerator/freezer units, and blood plasma freezers. These devices are specifically designed to maintain controlled temperatures for preserving blood components and plasma, ensuring they remain safe and viable for medical use.
Where is K2 Scientific, LLC based?
K2 Scientific, LLC is based in the United States. The company’s products are developed and manufactured domestically, adhering to U.S. medical device regulations.
Which regulatory registries list K2 Scientific, LLC’s devices?
K2 Scientific, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability in the healthcare supply chain.
How are K2 Scientific, LLC’s devices classified under FDA regulations?
K2 Scientific, LLC’s devices fall under FDA Class II regulatory classification. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.
What is the primary purpose of K2 Scientific, LLC’s blood storage devices?
The primary purpose of K2 Scientific, LLC’s blood refrigerators, refrigerator/freezer units, and plasma freezers is to store and preserve blood components and plasma at precise temperatures. This ensures the safety, viability, and sterility of the products for transfusion or further medical use, aligning with clinical and regulatory requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- k2sci.com
- —
- —
- [email protected]
- Phone
- 8002187613
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 080936069
Catalogue (19)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| K2 Scientific, LLC | K225GDRSSBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K225SDRSSBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K230SDRSSBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K230GDRSSBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K249SDRBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K215SDFBBBF | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K225SDRBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K225SDFBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K212GDRBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K249SDFBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K249GDRSSBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K225SDFSSBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K230SDRBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K249SDFSSBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K249GDRBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K225GDRBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K230GDRBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K249GDRSDSSBB | FDA UDI | Class II | Active |
| K2 Scientific, LLC | K249SDRSSBB | FDA UDI | Class II | Active |
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