Identity
- Trade Name
- Aurix Centrifuge FDA UDI
- Generic Name
- General-purpose centrifuge IVD FDA UDI
- Device Name
- Aurix Centrifuge with 010463 Aurix Centrifuge Machine Registration Label FDA UDI
- Model / Reference
- AGSC-04 FDA UDI
- Description
- Aurix Centrifuge with 010463 Aurix Centrifuge Machine Registration Label FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852714003095 FDA UDI
- FDA Product Code
- PMQ FDA UDI
- GMDN Term
- General-purpose centrifuge IVD 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose centrifuge IVD
Aurix Centrifuge by Nuo Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose centrifuge IVD.
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- Centrifuge 5920R — Eppendorf SE · Class A
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- Medical Centrifuge LX-210L750R — Qingdao Haier Biomedical Technology Co., Ltd. · Class A
- cence — HUNAN XIANG YI LABORATORY INSTRUMENT DEVELOPMENT CO.,LTD. · Class A
- 406 — GYROZEN · Class A
Cleared under the same submission
BK060007 also covers:
- 4TR — NUO THERAPEUTICS, INC.
- Aurix Eight Pack Kit — NUO THERAPEUTICS, INC.
- Aurix Five Pack Kit — NUO THERAPEUTICS, INC.
- Aurix Reagent Kit — NUO THERAPEUTICS, INC.
- Aurix Single Pack Kit — NUO THERAPEUTICS, INC.
- Aurix Ten Pack Kit — NUO THERAPEUTICS, INC.
- Aurix Wound Dressing Kit — NUO THERAPEUTICS, INC.
- Aurix Wound Dressing Kit — NUO THERAPEUTICS, INC.
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
- Nuo Therapeutics, Inc.
Sources (1)
- FDA UDI a587b533-f91d-4072-b9ca-beb69a5e9fa8 34 fields · synced May 30, 2026