BD Settling Chambers 491329

GUDID 30382904913299

BD Settling Chambers (96). Consumables for use on the PrepStain instrument.

TRIPATH IMAGING, INC.

Papanicolaou smear kit
Primary Device ID30382904913299
NIH Device Record Key709ca558-7255-492b-ae9a-2db28fd799f5
Commercial Distribution Discontinuation2018-05-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBD Settling Chambers
Version Model Number491329
Catalog Number491329
Company DUNS103318015
Company NameTRIPATH IMAGING, INC.
Device Count96
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-638-8663
Emailtechnical_services@bd.com
Phone800-638-8663
Emailtechnical_services@bd.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904913298 [Unit of Use]
GS130382904913299 [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 Number4
Public Version Date2019-04-05
Device Publish Date2015-05-05

On-Brand Devices [BD Settling Chambers]

30382904913305BD Settling Chambers
30382904913299BD Settling Chambers (96). Consumables for use on the PrepStain instrument.

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