BD PrepStain Slide Processor 490100

GUDID 00382904901004

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.

BECTON, DICKINSON AND COMPANY

Microscope slide maker/stainer IVD, automated

Primary Device ID	00382904901004
NIH Device Record Key	9c631f06-2a8f-4a18-88fd-5faf59b41e9d
Commercial Distribution Status	In Commercial Distribution
Brand Name	BD PrepStain Slide Processor
Version Model Number	490100
Catalog Number	490100
Company DUNS	122561087
Company Name	BECTON, DICKINSON AND COMPANY
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com
Phone	+1(800)638-8663
Email	Technical_Services@bd.com

Device Dimensions

Height	34 Inch
Height	34 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch
Depth	25 Inch
Width	40 Inch
Height	34 Inch

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904901004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P970018

FDA Product Code

MKQ	Processor, Cervical Cytology Slide, Automated

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-04-05
Device Publish Date	2015-07-22

On-Brand Devices [BD PrepStain Slide Processor]

00382904904074	PrepStain® Slide Processor (Refurb)
00382904901004	BD PrepStain® Slide Processor transfers cell samples from the specimen tubes to settling chambe