Identity
- Trade Name
- IVX Station Stock Solution Transfer Set FDA UDI
- Generic Name
- Compounding transfer set FDA UDI
- Device Name
- The IVX Station Stock Solution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration. FDA UDI
- Model / Reference
- IVX Station Stock Solution Transfer Set FDA UDI
- Description
- The IVX Station Stock Solution Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System for aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s) for use in the preparation of final compounded drugs for patient infusion administration. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007260407 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 Stock Solution Transfer Set by Omnicell, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 b3901fd2-f555-4777-b0b4-54afc758d4bc 34 fields · synced Jun 8, 2026