Identity
- Trade Name
- IV-pole holder TOF3D Variant B - Standard FDA UDI
- Generic Name
- Frame/rail/pole device holder FDA UDI
- Model / Reference
- 5750110 (Variant B) FDA UDI
Identifiers
- Catalog Number
- 5750110 FDA UDI
- Primary DI / UDI-DI
- EMIP5750110B0 FDA UDI
- 510(k) Number
- K212434 FDA UDI
- FDA Product Code
- KOI FDA UDI
- GMDN Term
- Frame/rail/pole device holder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2775 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Frame/rail/pole device holder
IV-pole holder TOF3D Variant B - Standard 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
K212434 also covers:
- EPSIMED — EPSIMED LLC
- Eye adapter TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Eye adapter TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Hand adapter TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Hand adapter TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IV-pole holder TOF3D Variant A - Premium — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IV-pole holder TOF3D Variant A - Premium — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- TOF3D - Neuromuscular Transmission Monitor — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Temperature sensor TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Temperature sensor TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Thumb adapter TOF3D — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Thumb adapter TOF3D — 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 3acd6ba2-713a-4317-bdba-cbab64f84d2f 35 fields · synced May 30, 2026