Identity
- Trade Name
- Expanse Blood Bank FDA UDI
- Generic Name
- Blood bank information system application software FDA UDI
- Device Name
- MEDITECH's Blood Bank Software is a Blood Establishment Computer System (BECS) that tightly integrates donor, unit and patient history information with data in the Electronic Health Record (EHR). The software's significant performance characteristics are flagging abnormal test results, reporting test and transfusion results, minimizing product waste, utilizing expert rules when recording and performing error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. FDA UDI
- Model / Reference
- Expanse FDA UDI
- Description
- MEDITECH's Blood Bank Software is a Blood Establishment Computer System (BECS) that tightly integrates donor, unit and patient history information with data in the Electronic Health Record (EHR). The software's significant performance characteristics are flagging abnormal test results, reporting test and transfusion results, minimizing product waste, utilizing expert rules when recording and performing error checks. It also generates turnaround time and workload statistics, compiles statistical reports, and automatically captures charges. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863529000148 FDA UDI
- FDA Product Code
- MMH FDA UDI
- GMDN Term
- Blood bank information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9165 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood bank information system application software
Expanse Blood Bank by Medical Information Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Medical Information Technology, Inc.
Sources (1)
- FDA UDI c9b50371-41bf-4619-8332-05b473d328ae 33 fields · synced May 30, 2026