Identity
- Trade Name
- SteriCUBE Filter Kit + FDA UDI
- Generic Name
- Sterilization container filter, single-use FDA UDI
- Device Name
- Filter Kit - 25 Cycles, including Filters, Indicator Locks, Ceramic Drain Filter, and Filter Separator FDA UDI
- Model / Reference
- SteriCUBE-PACK-025-FCSKIT FDA UDI
- Description
- Filter Kit - 25 Cycles, including Filters, Indicator Locks, Ceramic Drain Filter, and Filter Separator FDA UDI
Identifiers
- Catalog Number
- SteriCUBE-PACK-025-FCSKIT FDA UDI
- Primary DI / UDI-DI
- 00851489007222 FDA UDI
- 510(k) Number
- K152014 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Sterilization container filter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chemical/physical sterilization process indicatorSterilization container filter, single-use
SteriCUBE Filter Kit + by Stericube, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152014 also covers:
- MTS Filter Kit — Stericube, LLC
- MTS300 Cabinet, Getinge — Stericube, LLC
- MTS300 Cabinet, Steris, Evolution — Stericube, LLC
- MTS300 Cabinet, Steris, Standard — Stericube, LLC
- MTS300 Cabinet, Steris, Standard — Stericube, LLC
- MTS300 Cabinet, Steris, Standard — Stericube, LLC
- MTS300 Filter Kit — Stericube, LLC
- MTS300 Floor Loader, Getinge — Stericube, LLC
- MTS300 Transfer Cart, FL, Universal — Stericube, LLC
- MTS300 Transfer Cart, Getinge — Stericube, LLC
- MTS300 Transfer Cart, Steris, Evolution — Stericube, LLC
- MTS300 Transfer Cart, Steris, Standard — Stericube, LLC
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
- Stericube, LLC
Sources (1)
- FDA UDI a9062dae-1f2c-448c-88df-530b7c1d07b4 37 fields · synced May 30, 2026