Identity
- Trade Name
- HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM FDA UDI
- Generic Name
- Apheresis system FDA UDI
- Device Name
- MCS+ ,110V ENGL, LN 09000-110-E FDA UDI
- Model / Reference
- 09000-110-E FDA UDI
- Description
- MCS+ ,110V ENGL, LN 09000-110-E FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30812747012816 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
Yes
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
No
FDA UDI
Category: Apheresis system
Haemonetics Mcs+ (ln9000) Apheresis System by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Haemonetics Corporation
Sources (1)
- FDA UDI 1a53de9c-0104-46b4-8066-b46ebea097ee 35 fields · synced Jun 8, 2026