Isolette TI500 Transport Incubator
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Transportinkubator 500 EUDAMEDIsolette TI500 Transport Incubator FDA UDI
- Generic Name
- Conventional infant incubator FDA UDI
- Model / Reference
- MU20505 EUDAMEDFDA UDI000208 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098000208 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04049098000208 EUDAMED
- 510(k) Number
- K941106 FDA UDI
- FDA Product Code
- FPL FDA UDI
- EMDN Code
- Z1208040302 MOBILE NEONATAL INCUBATORS EUDAMED
- GMDN Term
- Conventional infant incubator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5410 FDA UDI
- Market of Registration
- Germany EUDAMED
- 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
No
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
Category: Conventional infant incubator
Isolette TI500 Transport Incubator by Draeger Medical Systems, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K941106 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (2)
- FDA UDI 67422945-177e-49e6-9c3e-0f6ff74da8e1 34 fields · synced Jul 15, 2026
- EUDAMED d37fb035-8ec3-40ce-8538-5a7441a64df9 61 fields · synced Jul 15, 2026