Identity
- Trade Name
- Aurora Software Version 1.3 Upgrade Kit FDA UDI
- Generic Name
- Apheresis system FDA UDI
- Device Name
- A software upgrade package (accessory) to the Aurora Plasmapheresis System (primary device). For collection of plasma by membrane filtration. FDA UDI
- Model / Reference
- 6R2013 FDA UDI
- Description
- A software upgrade package (accessory) to the Aurora Plasmapheresis System (primary device). For collection of plasma by membrane filtration. FDA UDI
Identifiers
- Catalog Number
- 6R2013 FDA UDI
- Primary DI / UDI-DI
- 04086000101059 FDA UDI
- FDA Product Code
- GKT FDA UDI
- GMDN Term
- Apheresis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Apheresis system
Aurora Software Version 1.3 Upgrade Kit by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Apheresis system.
- Trima Accel® — Terumo BCT, Inc.. · Class II
- Trima Accel® — Terumo BCT, Inc.. · Class II
- MCS+ — HAEMONETICS CORPORATION · Class II
- Angel Whole Blood Processing System — NUO THERAPEUTICS, INC. · Class II
- Trima Accel® — Terumo BCT, Inc.. · Class II
- MCS+ — HAEMONETICS CORPORATION · Class II
- HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM — HAEMONETICS CORPORATION · Class II
- Spectra Optia® — Terumo BCT, Inc.. · Class II
Cleared under the same submission
BK160012 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fresenius Kabi
Sources (1)
- FDA UDI 0906c405-f689-4018-8b4b-80a31cb53a3f 35 fields · synced May 30, 2026