BD SurePath™ PreCoat Slides

Basic Information

• Brand Name: BD SurePath™ PreCoat Slides
• Primary DI: 30382904912483
• Version / Model: 491248
• Catalog Number: 491248
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 96
• Record Status: Published
• Publish Date: 2017-09-08
• Public Version: 5
• Public Version Date: 2023-09-11
• Public Version Status: Update
• Public Device Record Key: 9a07146b-dc85-43e6-b5e7-81824c42fe8b

Device Description

BD SurePath™ PreCoat Slides (96)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKQ	Processor, Cervical Cytology Slide, Automated	Unknown		3
KEW	Slides, Microscope	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57951	Cervical cytology microscopy slide IVD	A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of a cervical cytology smear for analysis and/or other investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30382904912483	GS1
Unit of Use	00382904912482	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Height	11	Centimeter
Length	22	Centimeter
Width	11	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius