Identity
- Trade Name
- Corning FDA UDI
- Generic Name
- Blood/tissue storage/culture container FDA UDI
- Device Name
- Corning E-Cube Culture System Kit containing tubings, fittings, filters, and base; without 10-layer CellCube Module, 1 per pack, 1 per case FDA UDI
- Model / Reference
- 3286 FDA UDI
- Description
- Corning E-Cube Culture System Kit containing tubings, fittings, filters, and base; without 10-layer CellCube Module, 1 per pack, 1 per case FDA UDI
Identifiers
- Catalog Number
- 3286 FDA UDI
- Primary DI / UDI-DI
- H10832861 FDA UDI
- FDA Product Code
- KJA FDA UDI
- GMDN Term
- Blood/tissue storage/culture container FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.2240 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
The Corning E-Cube Culture System Kit is a single-use, implantable blood/tissue storage/culture container designed for hematology applications. This device features a variety of shapes and sizes, reducing the risk of contamination, allowing for freezing, and being gas permeable. It has a label stating that labeling does not contain MRI Safety Information.
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corning Incorporated
Sources (1)
- FDA UDI 45a5759b-fe21-4385-9d5b-37c58de363e9 36 fields · synced Jul 18, 2026