Identity
- Trade Name
- Blood Bank Information Management System FDA UDI
- Generic Name
- Blood bank information system application software FDA UDI
- Device Name
- BBIMS is Blood Establishment Computer Software. It is designed for use in a blood center to support the entry and eligibility processing for blood donors. It is used for manufacturing blood products and for shipping those products to customer hospitals for eventual transfusion. FDA UDI
- Model / Reference
- 2.06 FDA UDI
- Description
- BBIMS is Blood Establishment Computer Software. It is designed for use in a blood center to support the entry and eligibility processing for blood donors. It is used for manufacturing blood products and for shipping those products to customer hospitals for eventual transfusion. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857222008006 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood bank information system application software
Blood Bank Information Management System by Carter Bloodcare — 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
- Carter Bloodcare
Sources (1)
- FDA UDI e2bdf424-a66a-4064-9a4b-dd4f1c78e3e2 34 fields · synced May 30, 2026