DEVICE: Flow Set Pro (RUO A69184) (15099590205775)

Device Identifier (DI) Information

Flow Set Pro (RUO A69184)
A63492
In Commercial Distribution
A63492
Beckman Coulter, Inc.
15099590205775
GS1

1
008254708 *Terms of Use
Flow-Set Pro Fluorospheres
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
55864 Non-blood cell primer/calibrator/control material IVD, reagent
A substance or reactant intended to be used as a non-blood cell primer, calibrator and/or control to prepare or establish the operational performance of an instrument prior to its use in routine haematological analysis of a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PDX Flow Cytometry Calibrator
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130373 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

20cdd334-59fe-49cf-8c9e-7e2bacbafa18
July 06, 2018
3
September 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
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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