DEVICE: BD FACSCount™ (00382903390113)

Device Identifier (DI) Information

BD FACSCount™
339011
In Commercial Distribution
339011
BECTON, DICKINSON AND COMPANY
00382903390113
GS1

1
024230633 *Terms of Use
FACSCount CD4 Users Guide and Software
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Laboratory analyser operation system software IVD Mainframe or personal computer (PC) based operating system software (or firmware) that is specific to the central processing unit (CPU) incorporated into an analyser or analyser system. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used to identify different operating system versions.
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FDA Product Code

[?]
Product Code Product Code Name
GKZ Counter, differential cell
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K081213 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ce8c80da-e2c7-4d32-a752-3db6052665ec
July 06, 2018
3
June 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(877)232-8995
BDBCustomerService@bd.com
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