BD SurePath™ Preservative Fluid 491337

GUDID 00382904913373

BD SurePath™ Preservative Fluid (3600mL)

BECTON, DICKINSON AND COMPANY

Cytology fixative solution IVD

• Primary Device ID: 00382904913373
• NIH Device Record Key: 0781fd88-122e-4e75-b026-55a7de4edf57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD SurePath™ Preservative Fluid
• Version Model Number: 491337
• Catalog Number: 491337
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904913373 [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: 2019-06-25
• Device Publish Date: 2017-09-08

Devices Manufactured by BECTON, DICKINSON AND COMPANY

• 00382903649341 - BD Vacutainer Urine Complete Cup Kit: 2026-02-11 KIT URINCOL 13x75C&S16x100CONUA16x100UA
• 00382904051600 - 20G 1 1/4IN sterile Spinal Introducer needle: 2026-02-06 NEEDLE SP S/SU 20GA 1-1/4IN INTRODUCER
• 00382904490850 - NMIC-315: 2026-02-06 BD Phoenix™ NMIC-315
• 00382903033300 - BD SafetyGlide: 2026-02-05 SYRINGE ALRG SFTYGLD 1ML W/NDL 27X3/8 IB
• 30382903648154 - BD Vacutainer® One Use Holder: 2026-02-05 HOLDER ONE USE NONSTACKABLE
• 30382903672906 - BD Vacutainer® Multiple Sample Luer Adapter: 2026-02-05 BD Vacutainer® Multiple Sample Luer Adapter
• 50382903678438 - BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection Tubes: 2026-02-04 TUBE EDTA PLC 13X75 2.0 PLBL LAV
• 00382902451228 - BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes: 2026-01-15 BD BBL™ MGIT™ Mycobacteria Growth Indicator Tubes, 7 mL, carton of 100 tubes