BD SurePath™ Manual Method Kit

Basic Information

• Brand Name: BD SurePath™ Manual Method Kit
• Primary DI: 00382904912666
• Version / Model: 491266
• Catalog Number: 491266
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: bb53cd18-6eaa-45a4-a93a-31b093630808

Device Description

BD SurePath™ Manual Method Kit: BD SurePath™ PreCoat slides (5 X 96) & BD Settling Chambers (2 X 240)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
65667	Endocervical specimen cytological examination kit IVD	A collection of noninvasive in vitro diagnostic devices intended to be used in the clinical laboratory for the preparation, processing, and microscopic examination of an endocervical cytological specimen previously collected from a patient, typically as part of a woman's regular pelvic examination and cervical cancer screening. It may be referred to as Papanicolaou (Pap) smear test and typically consists of specimen suspension homogenization reagents and preservatives, cytological centrifuge funnels, fixative/stain solutions, and microscopy slides. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382904912666	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970018	000

Storage Conditions

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