AccessGUDID - DEVICE: BD PrepStain Slide Processor (00382904901004)

GUDID

Device Identifier (DI) Information

Brand Name: BD PrepStain Slide Processor
Version or Model: 490100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 490100
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382904901004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD PrepStain® Slide Processor transfers cell samples from the specimen tubes to settling chambers mounted to microscope slides. The instrument then automatically stains and rinses each slide

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37974	Microscope slide maker/stainer IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used to prepare, transfer or fix blood, tissue or other clinical specimens onto microscope examination slides, and then stain the slides using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKQ	Processor, Cervical Cytology Slide, Automated

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970018	000

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 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Depth: 25 Inch
Width: 40 Inch
Height: 34 Inch

Device Record Status

Public Device Record Key: 9c631f06-2a8f-4a18-88fd-5faf59b41e9d
Public Version Date: July 01, 2024
Public Version Number: 7
DI Record Publish Date: July 22, 2015