BD PrepStain Slide Processor

Basic Information

• Brand Name: BD PrepStain Slide Processor
• Primary DI: 00382904901004
• Version / Model: 490100
• Catalog Number: 490100
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-22
• Public Version: 6
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 9c631f06-2a8f-4a18-88fd-5faf59b41e9d

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKQ	Processor, Cervical Cytology Slide, Automated	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382904901004	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P970018	000

Device Sizes

Type	Value	Unit	Text
Depth	25	Inch
Width	40	Inch
Height	34	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius