Identity
- Trade Name
- Trolley Tesla DUO including MFI FDA UDI
- Generic Name
- Electromechanical device/system transport trolley FDA UDI
- Model / Reference
- Trolley Tesla DUO including MFI FDA UDI
Identifiers
- Catalog Number
- 6300040 FDA UDI
- Primary DI / UDI-DI
- EMIP63000400 FDA UDI
- 510(k) Number
- K153739 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Electromechanical device/system transport trolley FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Electromechanical device/system transport trolley
Trolley Tesla DUO including MFI by MIPM Mammendorfer Institut für Physik und Medizin GmbH — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K153739 also covers:
- MRI Patient Moitor Tesla DUO — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- TeslaDUO Remote Control — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Trolley TeslaDUO including MFI — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Wireless Pulse Oximetry Sensor for Tesla DUO — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Wireless Pulse Oximetry Sensor for TeslaDUO — MIPM Mammendorfer Institut für Physik und Medizin GmbH
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
Sources (1)
- FDA UDI 8d47d891-42e8-4586-8aae-855a088eccae 35 fields · synced May 30, 2026