PrepStain® Settling Chambers

Basic Information

• Brand Name: PrepStain® Settling Chambers
• Primary DI: 30382904905201
• Version / Model: 490520
• Catalog Number: 490520
• Company Name: TRIPATH IMAGING, INC.
• Labeler DUNS: 103318015
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 96
• Record Status: Published
• Publish Date: 2015-05-05
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 2a08c648-172b-4b5c-8d86-8ba074fca20e
• Distribution End Date: 2015-08-26

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: No
• 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
12955	Papanicolaou smear kit	A packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30382904905201	GS1
Unit of Use	00382904905201	GS1

Premarket Submissions

Submission Number	Supplement Number
P970018	000