Astotherm Plus, Astotubes, Astoline
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ASTOTHERM PLUS EUDAMEDASTOTHERM® PLUS FDA UDI
- Generic Name
- Conduction blood/fluid warmer FDA UDI
- Device Name
- ASTOTHERM PLUS control unit EUDAMEDASTOTHERM PLUS EUDAMEDBlood and infusion warmer FDA UDI
- Model / Reference
- AP220SEU EUDAMEDFDA UDIAP220SUK EUDAMEDFDA UDIAP220CN EUDAMEDAP220CH EUDAMEDAP220SDK EUDAMEDAP220SCN EUDAMED
- Description
- Blood and infusion warmer FDA UDI
Identifiers
- Catalog Number
- AP220SEU FDA UDIAP220SUK FDA UDI
- Primary DI / UDI-DI
- 04260114140382 EUDAMEDFDA UDI04260114140474 EUDAMEDFDA UDI04260114140979 EUDAMED04260114140962 EUDAMED04260114141020 EUDAMED04260114141013 EUDAMED
- Basic UDI-DI
- B-04260114140382 EUDAMEDB-04260114140474 EUDAMEDB-04260114140979 EUDAMEDB-04260114140962 EUDAMEDB-04260114141020 EUDAMEDB-04260114141013 EUDAMED
- 510(k) Number
- FDA Product Code
- BSB FDA 510(k)FDA UDI
- EMDN Code
- A030105 FLUIDS HEATING SYSTEMS EUDAMED
- GMDN Term
- Conduction blood/fluid warmer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 864.9205 FDA 510(k)
- Regulation Number
- 864.9205 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMEDNorthern Ireland EUDAMEDDenmark EUDAMED
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Astotherm Plus, Astotubes, and Astoline are Blood Warmers, Non-Electromagnetic Radiation designed to maintain and elevate the temperature of blood and intravenous infusions during clinical procedures. These devices ensure thermal regulation to mitigate perioperative hypothermia by warming fluids to safe, physiologically compatible levels prior to administration.
Supplied as a modular system, the Astotherm Plus includes reusable warming units (Astoline) and single-use warming tubes (Astotubes) for compatibility with standard transfusion and infusion lines. The system operates in operating rooms (OR) and intensive care units (ICU), with models like the AP220 achieving operational readiness in under 60 seconds. Authorized under FDA 510(k), MDD, and MDR, these devices adhere to Class II regulatory standards (864.9205) and are intended for single-use components (Astotubes) while the Astoline warming unit is reusable. Storage and handling follow sterile protocols for single-use components, with no MRI safety restrictions.
Frequently asked questions
What clinical settings are the Astotherm Plus system and its components designed to operate in?
The Astotherm Plus system, including the Astoline warming unit and Astotubes, is specifically designed for use in operating rooms (OR) and intensive care units (ICU). These environments require precise temperature control for blood and intravenous infusions to prevent perioperative hypothermia, ensuring fluids are warmed to safe, physiologically compatible levels before administration.
Are the Astotubes single-use or reusable, and how does this affect their handling and storage?
The Astotubes are intended for single-use only, meaning each tube is designed to be discarded after one use. This requires adherence to sterile protocols during storage and handling to maintain safety and efficacy. The reusable component of the system, the Astoline warming unit, can be used repeatedly, but the single-use tubes must be replaced after each procedure.
How quickly can the Astotherm Plus system be prepared for use, and what does this mean for clinical workflow?
The Astotherm Plus system, specifically the AP220 model, is noted for achieving operational readiness in under 60 seconds. This rapid setup time helps streamline clinical workflows in time-sensitive environments like operating rooms or intensive care units, reducing delays in warming blood or intravenous infusions before administration.
What regulatory standards does the Astotherm Plus system comply with, and what does this imply about its safety and approval process?
The Astotherm Plus system, including the Astoline and Astotubes, is authorized under FDA 510(k), MDD, and MDR regulations, adhering to Class II standards (864.9205). This classification implies that the device has undergone rigorous review by regulatory bodies to ensure its safety and effectiveness for maintaining and elevating the temperature of blood and infusions, while also meeting specific performance and manufacturing requirements.
Can the Astotherm Plus system be used with standard transfusion and infusion lines, and how does the modular design support compatibility?
Yes, the Astotherm Plus system is designed to be compatible with standard transfusion and infusion lines. The modular system includes reusable warming units (Astoline) and single-use warming tubes (Astotubes), allowing for easy integration with existing clinical setups. This flexibility ensures seamless use in various medical procedures where precise temperature control of fluids is required.
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: Astotherm® Plus - Gentherm Medical, PDF ASTOTHERM® plus Rapid, safe and highly efficient warming of blood and ..., ASTOTHERM PLUS, ASTOTUBES, ASTOLINE (K991160) — FDA 510 (k) | Innolitics
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K991160 | Class II | Active |
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Manufacturer
- Manufacturer
- Stihler Electronic Gmbh
Sources (9)
- FDA 510(k) K991160 24 fields · synced Sep 18, 2026
- FDA UDI e75e056a-f258-458e-9055-3d56918fdde1 35 fields · synced May 30, 2026
- FDA UDI 0482c04b-c4d4-4f08-9316-984fd0f1148f 35 fields · synced May 30, 2026
- EUDAMED 139b807f-556f-47c9-bb73-21b144fe8432 61 fields · synced Jul 9, 2026
- EUDAMED f97120d7-9305-485e-a13f-1cd0b5c0a8c8 61 fields · synced Jul 11, 2026
- EUDAMED 1441f391-890e-4e6c-8e09-e10198295131 61 fields · synced Jul 15, 2026
- EUDAMED 2d3d54f4-736d-4ee1-afcd-4776cc66a872 61 fields · synced Jul 24, 2026
- EUDAMED 572ef211-055b-4e32-9bda-469adce8a2ca 61 fields · synced Aug 2, 2026
- EUDAMED eddc0bf4-2916-4f65-88a6-c721d8c6f288 61 fields · synced Aug 4, 2026