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Oracle Health Blood Bank

FDA UDI

Class II (US FDA UDI)

by Cerner Corporation

Identity

Trade Name
Oracle Health Blood Bank FDA UDI
Generic Name
Blood bank information system application software FDA UDI
Model / Reference
PathNet Blood Bank Transfusion 2012 FDA UDI

Identifiers

Primary DI / UDI-DI
00853023006098 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

Oracle Health Blood Bank by Cerner Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood bank information system application software.

Cleared under the same submission

BK990007 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cerner Corporation

Sources (1)

  • FDA UDI 0c4355fc-4695-43b6-bb7e-97b62f7ec08c 33 fields · synced May 30, 2026