Giraffe Incubator Carestation CS1
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213553 FDA 510(k)
- FDA Product Code
- FMZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5400 FDA 510(k)
- Regulation Number
- 880.5400 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Giraffe Incubator Carestation CS1 is a neonatal incubator designed to provide a controlled environment for premature and newborn infants. It combines advanced temperature regulation, humidity control, and monitoring capabilities to support critical care needs in neonatal units, ensuring optimal physiological stability for vulnerable patients.
This device is supplied as a reusable medical system intended for use in general hospital settings, with regulatory authorisations including FDA 510K clearance under the Traditional pathway. It operates within Class II medical device standards and is regulated under the applicable FDA regulation number 880.5400. The system is engineered for integration with neonatal care protocols, adhering to sterility and safety protocols as defined by its manufacturer and regulatory compliance requirements.
Frequently asked questions
What types of neonatal patients is the Giraffe Incubator Carestation CS1 designed to support in a hospital setting?
The Giraffe Incubator Carestation CS1 is specifically designed to provide a controlled environment for premature and newborn infants requiring critical care. Its advanced temperature regulation, humidity control, and monitoring capabilities help maintain optimal physiological stability for vulnerable neonatal patients in general hospital settings.
How is the Giraffe Incubator Carestation CS1 supplied, and is it intended for single-use or reusable applications?
The Giraffe Incubator Carestation CS1 is supplied as a reusable medical system, meaning it is engineered for repeated use in neonatal care protocols after proper cleaning, disinfection, and maintenance as outlined by the manufacturer. It is not intended for single-use.
What regulatory pathway was followed for FDA clearance of the Giraffe Incubator Carestation CS1, and what class does it fall under?
The Giraffe Incubator Carestation CS1 received FDA clearance under the Traditional 510(k) pathway, classified as a Class II medical device. It was determined to be substantially equivalent to a predicate device and is regulated under FDA regulation number 880.5400 for neonatal incubators.
Does the Giraffe Incubator Carestation CS1 come in multiple sizes or models, and how would I identify the correct one for my facility?
The device is listed under multiple FEI numbers (e.g., 2510954, 3009077524, etc.) and registration numbers, which correspond to different product codes (FMZ) and potentially varying configurations or accessories. While the core system remains consistent, the specific model or size may be determined by the included features or accessories tied to these identifiers. Contacting the manufacturer’s support team with your facility’s requirements would help confirm compatibility.
What storage and maintenance protocols should be followed for the Giraffe Incubator Carestation CS1 to ensure sterility and longevity?
As a reusable device, the Giraffe Incubator Carestation CS1 must be cleaned, disinfected, and maintained according to the manufacturer’s guidelines to preserve sterility and functionality. Storage should follow the manufacturer’s recommendations, typically in a clean, dry environment protected from extreme temperatures or moisture. Detailed instructions for cleaning, disinfection, and maintenance are provided in the device’s operational manual.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213553 | Class II | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- FDA Applicant
- Datex Ohmeda, Inc.
Sources (2)
- FDA 510(k) K213553 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 11, 2026