Identity
- Trade Name
- IVX Station Reconstitution Transfer Set FDA UDI
- Generic Name
- Compounding transfer set FDA UDI
- Device Name
- The IVX Station Reconstitution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic reconstitution of lyophilized drug in vial(s) from an I.V. bag source for use in the preparation of final compounded drugs for patient infusion administration. FDA UDI
- Model / Reference
- IVX Station Reconstitution Transfer Set FDA UDI
- Description
- The IVX Station Reconstitution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic reconstitution of lyophilized drug in vial(s) from an I.V. bag source for use in the preparation of final compounded drugs for patient infusion administration. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007260421 FDA UDI
- 510(k) Number
- K212530 FDA UDI
- FDA Product Code
- LHI FDA UDI
- GMDN Term
- Compounding transfer set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Compounding transfer set
IVX Station Reconstitution Transfer Set by Omnicell, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Compounding transfer set.
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Cleared under the same submission
K212530 also covers:
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
- Omnicell, Inc.
Sources (1)
- FDA UDI 3b5aadc5-51b9-42fe-9a36-2715c8365b83 34 fields · synced Jun 8, 2026