BD SurePath™ PreCoat Slides 491248

GUDID 30382904912483

BD SurePath™ PreCoat Slides (96)

BECTON, DICKINSON AND COMPANY

Papanicolaou smear kit

Primary Device ID	30382904912483
NIH Device Record Key	9a07146b-dc85-43e6-b5e7-81824c42fe8b
Commercial Distribution Status	In Commercial Distribution
Brand Name	BD SurePath™ PreCoat Slides
Version Model Number	491248
Catalog Number	491248
Company DUNS	122561087
Company Name	BECTON, DICKINSON AND COMPANY
Device Count	96
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	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
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

Device Dimensions

Width	11 Centimeter
Width	11 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter
Height	11 Centimeter
Length	22 Centimeter
Width	11 Centimeter

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
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	00382904912482 [Unit of Use]
GS1	30382904912483 [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

30382902560921 - BD Veritor System for Rapid Detection of SARS-CoV-2	2025-08-29 Veritor SARS-CoV2 assay Gen 2
30382902561386 - BD Veritor SARS-CoV-2 Control Swab Set	2025-08-29 Veritor COVID Gen 2 control swab set
00382904413576 - BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens	2025-08-25 BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens Contains: 100 each sterile polyester-tipped cleaning swab,
00382904413583 - Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays	2025-08-25 Swab Male Urethral Specimen Collection
00382903059041 - BD SafetyGlide	2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
00382903059058 - BD SafetyGlide	2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB
00382903059065 - BD SafetyGlide	2025-08-07 SYRINGE 3ML LL W/NDL SFTYGLD 22X1-1/2 RB
00382903059096 - BD SafetyGlide	2025-08-07 SYR 3ML LL W/NDL SFTYGLD 21X1-1/2 RB TW