DEVICE: BD FACSCanto™ (00382906577702)

Device Identifier (DI) Information

BD FACSCanto™
657770
In Commercial Distribution
657770
BECTON, DICKINSON AND COMPANY
00382906577702
GS1

1
024230633 *Terms of Use
FACSCanto 3.0 SW without dongle
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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 [?]
K041074 000
No CLOSE

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

d3db9566-f697-44e1-ad81-d3e755b0b07f
July 06, 2018
3
June 08, 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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