Unique Temp Warming Blankets, Model 8001140XXX
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K093244 FDA 510(k)
- FDA Product Code
- DWJ 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 Unique Temp Warming Blankets, Model 8001140XXX is a System, Thermal Regulating device classified under the Cardiovascular medical specialty. It is designed to regulate patient temperature through thermal management.
This device is supplied as a patient warming system and is intended for use in clinical settings. It has received FDA 510(k) clearance under K093244 and is classified as a Class II medical device. The device is reusable and non-sterile, with no MRI safety information provided in the data.
Frequently asked questions
What is the Unique Temp Warming Blankets Model 8001140XXX used for?
It is designed to regulate patient temperature through thermal management in clinical settings, specifically classified under the Cardiovascular medical specialty for thermal regulation during procedures.
Is the Unique Temp Warming Blankets Model 8001140XXX sterile or non-sterile, and is it reusable?
The device is supplied as non-sterile and is designed for reuse, meaning it can be cleaned and used multiple times following the manufacturer's reprocessing instructions.
What regulatory pathway was used for the Unique Temp Warming Blankets Model 8001140XXX?
It received FDA 510(k) clearance under submission K093244, indicating it was found substantially equivalent to a legally marketed predicate device.
What is the device classification and product code for the Unique Temp Warming Blankets Model 8001140XXX?
It is classified as a Class II medical device with product code DWJ, falling under the Cardiovascular specialty and regulation number 870.5900 for thermal regulating systems.
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: GERATHERM UNIQUETEMP INSTRUCTION MANUAL Pdf Download, UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX (K093244) — FDA 510(k ..., Geratherm UniqueTemp Manuals | ManualsLib, UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX 510(k) K093244 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093244 | Class II | Active |
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Manufacturer
- Manufacturer
- Geratherm Medical AG
Sources (1)
- FDA 510(k) K093244 24 fields · synced Sep 27, 2026