BD SurePath™ Collection Vial Kit 500

Basic Information

• Brand Name: BD SurePath™ Collection Vial Kit 500
• Primary DI: 10382904912533
• Version / Model: 491253
• Catalog Number: 491253
• Company Name: TRIPATH IMAGING, INC.
• Labeler DUNS: 103318015
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2017-09-08
• Public Version: 7
• Public Version Date: 2021-10-18
• Public Version Status: Update
• Public Device Record Key: 10a33477-9999-49df-90a7-873db856abb3
• Distribution End Date: 2021-10-18

Device Description

BD SurePath™ Collection Vial Kit 500: BD SurePath™ Collection Vials (500)

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

GMDN Terms

Code	Name	Definition	Implantable	Status
57952	Cytology specimen container IVD, transport buffer	A covered receptacle containing transport buffer solution intended to be used for the collection, preservation, and transport of a cytology specimen (e.g., oral, cervical, colonic) for in vitro diagnostic investigation [e.g., histopathological cervical cancer screening]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10382904912533	GS1
Unit of Use	00382904912536	GS1
Package	30382904912537	GS1	Shelf Pack	20	Not in Commercial Distribution	2021-10-18

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970018	032

Storage Conditions

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