AccessGUDID - DEVICE: BD FocalPoint™ GS Review Station (00382904901899)

GUDID

Device Identifier (DI) Information

Brand Name: BD FocalPoint™ GS Review Station
Version or Model: 490189
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 490189
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904901899
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD FocalPoint™ GS Review Station Computer

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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

GMDN Preferred Term Name	GMDN Definition
Cell morphology analyser IVD, manual	A mains electricity (AC-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 and operates with technician involvement in most procedural steps.

GMDN Preferred Term Name

GMDN Definition

Cell morphology analyser IVD, manual

A mains electricity (AC-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 and operates with technician involvement in most procedural steps.

FDA Product Code

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Product Code	Product Code Name
MNM	Reader, Cervical Cytology Slide, Automated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950009	008

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Height: 33.2 Centimeter
Width: 55 Centimeter
Length: 59.2 Centimeter

Device Record Status

Public Device Record Key: 46aa5b73-5556-483e-ad3d-15e069e7d18a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 08, 2017