BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush 491438

GUDID 00382904914387

BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush

BECTON, DICKINSON AND COMPANY

Papanicolaou smear kit
Primary Device ID00382904914387
NIH Device Record Key20e25fbf-6bb0-4545-973b-3cdcbce831d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD SurePath™ GYN Preservative Vial Kit with Cervex-Brush
Version Model Number491438
Catalog Number491438
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)638-8663
EmailTechnical_Services@bd.com
Phone+1(800)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
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
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
GS100382904914387 [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 Date2016-06-23

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00382903059058 - BD SafetyGlide2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB
00382903059065 - BD SafetyGlide2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 22X1-1/2 RB
00382903059096 - BD SafetyGlide2025-08-07 SYR 3ML LL W/NDL SFTYGLD 21X1-1/2 RB TW
00382903059157 - BD SafetyGlide2025-08-07 NEEDLE SFTYGLD 21X1 RB TW
00382903059164 - BD SafetyGlide2025-08-07 NEEDLE SFTYGLD 25X1 RB
00382903059171 - BD SafetyGlide2025-08-07 NEEDLE SFTYGLD 21X1-1/2 RB TW
00382903059188 - BD SafetyGlide2025-08-07 NEEDLE SFTYGLD 18X1-1/2 RB

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