BD PrepStain™ Install Kit 491289

GUDID 00382904912895

BD PrepStain™ Install Kit

BECTON, DICKINSON AND COMPANY

Papanicolaou smear kit Papanicolaou smear kit Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD Endocervical specimen cytological examination kit IVD

• Primary Device ID: 00382904912895
• NIH Device Record Key: 851f9e93-e950-4fb0-af2b-517b46ff7ff5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD PrepStain™ Install Kit
• Version Model Number: 491289
• Catalog Number: 491289
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904912895 [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: 4
• Public Version Date: 2019-04-05
• Device Publish Date: 2017-09-08

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 00382904440756 - BD Onclarity™ HPV Assay Reagent Pack: 2024-05-07 Kit HPV Assay Reagent for BD COR US
• 00382906635419 - N/A: 2024-04-29 BD® CD23 (EBVCS-5) PE-Cy7
• 00382903050284 - BD Sharps Collector: 2024-04-26 SHARPS COLL 17GAL HINGE PHARWASTE
• 00382903050536 - BD Recykleen™ Sharps Collector: 2024-04-26 SHARPS COLL 3GAL RECYKLEEN PEARL
• 00382903050543 - BD Recykleen™ Sharps Collector: 2024-04-26 SHARPS COLL 3GAL RECYKLEEN RED
• 00382903050581 - BD Recykleen™ Sharps Collector: 2024-04-26 SHARPS COLL NEXT GEN 5.4QT PHARM RECYK
• 00382903050765 - BD Sharps Collector: 2024-04-26 SHARPS COLL CHEMO 3GAL YELLOW NEW CAP
• 00382903051601 - BD Recykleen™ Sharps Collector: 2024-04-26 SHARPS COLL 6GAL RED SMALL OPEN CAP