DEVICE: BD FocalPoint™ GS Review Station (00382904901899)

Device Identifier (DI) Information

BD FocalPoint™ GS Review Station
490189
In Commercial Distribution
490189
BECTON, DICKINSON AND COMPANY
00382904901899
GS1

1
122561087 *Terms of Use
BD FocalPoint™ GS Review Station Computer
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
15132 Cell morphology analyser IVD, manual
An electrically-powered manual laboratory instrument intended to be used for the qualitative microscopic examination of blood or other clinical specimens in order to view, count, record and evaluate the morphological characteristics of cells and other biological components. The device typically includes a microscope, camera, monitor and software package.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MNM Reader, Cervical Cytology Slide, Automated
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P950009 008
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Height: 33.2 Centimeter
Width: 55 Centimeter
Length: 59.2 Centimeter
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Device Record Status

46aa5b73-5556-483e-ad3d-15e069e7d18a
August 26, 2024
6
September 08, 2017
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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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)638-8663
technical_services@bd.com
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