FDA UDI
In Commercial Distribution
🇺🇸 United States
Reveos® Automated Whole Blood Processing System
DI: 05020583001145
·
Model: 24000
·
TERUMO BCT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Reveos® Automated Whole Blood Processing System
- Primary DI
- 05020583001145
- Version / Model
- 24000
- Company Name
- TERUMO BCT, INC.
- Labeler DUNS
- 801679200
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-06
- Public Version
- 1
- Public Version Date
- 2025-08-14
- Public Version Status
- New
- Public Device Record Key
- c96ecaf1-34d6-4d7d-b954-91f51d6df3a7
Device Description
Reveos® Automated Whole Blood Processing System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MYY | Separator, Semi-Automated, Blood Component | Unknown | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15115 | Blood bank centrifuge | An electrically-powered device intended to be used in a blood donor facility to process large volumes of blood using centrifugal force, usually to separate red blood cells or platelets from plasma for subsequent patient infusion, storage, or further processing. It is typically a large stationary structure with an electric motor, a shaft, a tachometer, and speed and time controls; it also includes a rotor for mounting one of several interchangeable heads with slots to fit sample holders (tubes/bags). It may additionally have refrigeration capabilities to perform temperature-sensitive procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05020583001145 | GS1 |
Customer Contacts
- Phone
- +1(877)339-4228
- [email protected]