Identity
- Trade Name
- Isolette 8000 plus FDA UDI
- Generic Name
- Conventional infant incubator FDA UDI
- Device Name
- Incubator, neonatal FDA UDI
- Model / Reference
- MU20602 FDA UDI
- Description
- Incubator, neonatal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048675020530 FDA UDI
- 510(k) Number
- K182977 FDA UDI
- FDA Product Code
- FMZ FDA UDI
- GMDN Term
- Conventional infant incubator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Conventional infant incubator
Isolette 8000 plus by Draeger Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (1)
- FDA UDI 34c559d6-83ab-4ef8-8b0f-2c5a5e94e476 35 fields · synced Jun 9, 2026