Identity
- Trade Name
- Cyclone Bone Marrow Concentration System 60mL FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Model / Reference
- CYC-60-01 FDA UDI
Identifiers
- Catalog Number
- CYC-60-01 FDA UDI
- Primary DI / UDI-DI
- 00855306003244 FDA UDI
- 510(k) Number
- K070666 FDA UDI
- FDA Product Code
- JQC FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Haematological concentrate system preparation kit, platelet concentrationHaematological concentrate system preparation kit, bone marrow concentration
Cyclone Bone Marrow Concentration System 60mL by EmCyte Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K070666 also covers:
- AbsoluteBMC 120mL GenesisCS Component Concentrating System — EmCyte Corporation
- AbsoluteBMC 30mL GenesisCS Component Concentrating System — EmCyte Corporation
- AbsoluteBMC 60mL GenesisCS Component Concentrating System — EmCyte Corporation
- Accelerate II Bone Marrow Concentrating System 120mL — EmCyte Corporation
- Accelerate II Bone Marrow Concentrating System 60mL — EmCyte Corporation
- Cyclone Bone Marrow Concentration System 120mL — EmCyte Corporation
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
- EmCyte Corporation
Sources (1)
- FDA UDI aeb4f3ee-2bc4-4699-a53a-68ddd73abea4 36 fields · synced Jun 9, 2026