Isolette 8000 Plus Neonatal Incubator
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Isolette 8000 plus EUDAMEDIsolette® 8000 plus FDA UDI
- Generic Name
- Conventional infant incubator FDA UDI
- Device Name
- I8000 plus FDA UDI
- Model / Reference
- MU20602 EUDAMEDFDA UDI090612 EUDAMED
- Description
- I8000 plus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049098090612 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04049098090612 EUDAMED
- FDA Product Code
- FMZ FDA 510(k)FDA UDI
- EMDN Code
- Z1208040301 FIXED NEONATAL INCUBATORS EUDAMED
- GMDN Term
- Conventional infant incubator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 880.5400 FDA 510(k)
- Regulation Number
- 880.5400 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General Hospital 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
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
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
Yes
Manufacturing Date
Yes
The Isolette 8000 Plus is a neonatal incubator designed to provide a controlled thermal, humidified, and sterile environment for premature and low-birth-weight infants. It maintains precise temperature, humidity, and oxygen levels to support critical care and promote stable physiological conditions in neonatal patients.
This device is intended for use in general hospital settings, including neonatal intensive care units (NICUs). Supplied as a reusable medical device, it requires proper cleaning, disinfection, and maintenance to ensure sterility and functionality. The Isolette 8000 Plus complies with FDA 510(k) clearance under Special Review (K182977) and adheres to the Medical Device Directive (MDD). It is classified as a Class II device under the FDA’s regulatory framework.
Frequently asked questions
Is the Isolette 8000 Plus designed for single-use or can it be reused in a clinical setting?
The Isolette 8000 Plus is supplied as a reusable medical device. To maintain sterility and functionality, it requires proper cleaning, disinfection, and maintenance between uses, as outlined in the manufacturer’s guidelines.
What types of clinical environments is the Isolette 8000 Plus intended for?
The Isolette 8000 Plus is intended for use in general hospital settings, including neonatal intensive care units (NICUs), where it provides controlled thermal, humidified, and sterile conditions for premature and low-birth-weight infants.
How does the Isolette 8000 Plus ensure a stable environment for neonatal patients?
The Isolette 8000 Plus maintains precise temperature, humidity, and oxygen levels to create a controlled environment that supports critical care and promotes stable physiological conditions for premature or low-birth-weight infants.
What regulatory pathways has the Isolette 8000 Plus followed for market authorization?
The Isolette 8000 Plus has received FDA 510(k) clearance under Special Review (K182977) and complies with the Medical Device Directive (MDD). It is classified as a Class II device under FDA regulations.
Are there multiple model variants of the Isolette 8000 Plus, and if so, how are they differentiated?
The provided data lists multiple registration numbers (e.g., 1055236, 2510954, etc.) associated with the Isolette 8000 Plus, which may indicate different model variants or configurations. However, the specific differences between these variants are not detailed in the provided information.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K182977 | Class II | Active |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (3)
- FDA 510(k) K182977 24 fields · synced Oct 6, 2026
- FDA UDI 3fd42f2c-db0e-4230-9c23-9fef3fac8679 35 fields · synced May 29, 2026
- EUDAMED ad93eb7c-122c-41c5-a561-81169beda754 61 fields · synced Jul 16, 2026