Identity
- Trade Name
- Dr.PRP FDA UDI
- Generic Name
- Apheresis system FDA UDI
- Device Name
- The Dr.PRP is provided as individually packaged sterile, single-use, disposable concentrating unit which is composed of medical grade polymer and elastomer. The concentrating unit has 20 ml of volume capacity and is designed to work with a swing rotor type general-purpose centrifuge. FDA UDI
- Model / Reference
- Dr.PRP FDA UDI
- Description
- The Dr.PRP is provided as individually packaged sterile, single-use, disposable concentrating unit which is composed of medical grade polymer and elastomer. The concentrating unit has 20 ml of volume capacity and is designed to work with a swing rotor type general-purpose centrifuge. FDA UDI
Identifiers
- Catalog Number
- RMLFT-001(EN) FDA UDI
- Primary DI / UDI-DI
- 08809410200008 FDA UDI
- FDA Product Code
- ORG 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
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
No
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
Category: Apheresis system
Dr.PRP by Rmedica Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK230818 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
- Rmedica Co., Ltd
Sources (1)
- FDA UDI 2d70ad0d-d958-4fd1-8d67-4617e134d491 37 fields · synced Jun 6, 2026