BD PrepStain Slide Processor 490985

GUDID 00382904909857

BD PrepMate™ Instrument 115 v (Refurbished)

TRIPATH IMAGING, INC.

Papanicolaou smear kit Papanicolaou smear kit
Primary Device ID00382904909857
NIH Device Record Keyd58b4494-960b-48a7-9c94-0783dc10af99
Commercial Distribution Discontinuation2017-05-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBD PrepStain Slide Processor
Version Model Number490985
Catalog Number490985
Company DUNS103318015
Company NameTRIPATH IMAGING, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-863-8663
Emailtechnical_services@bd.com
Phone1-800-863-8663
Emailtechnical_services@bd.com

Device Dimensions

Depth23 Inch
Depth23 Inch
Depth23 Inch
Height21 Inch
Width12.5 Inch
Depth23 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904909857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKQProcessor, Cervical Cytology Slide, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-22

On-Brand Devices [BD PrepStain Slide Processor]

00382904909857BD PrepMate™ Instrument 115 v (Refurbished)
00382904904104BD PrepMate™ Automated Accessory (115V)
00382904901042BD PrepMate™ Automated Accessory(220V)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.