BD Settling Chambers 491330

GUDID 30382904913305

BD Settling Chambers

TRIPATH IMAGING, INC.

Papanicolaou smear kit

• Primary Device ID: 30382904913305
• NIH Device Record Key: cbe48c6e-4d1a-4841-be57-927b3e79ba4a
• Commercial Distribution Discontinuation: 2018-05-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BD Settling Chambers
• Version Model Number: 491330
• Catalog Number: 491330
• Company DUNS: 103318015
• Company Name: TRIPATH IMAGING, INC.
• Device Count: 240
• 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: false
• 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: 800-638-8663
• Email: technical_services@bd.com
• Phone: 800-638-8663
• Email: technical_services@bd.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904913304 [Unit of Use]
GS1	30382904913305 [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: 2015-05-05

On-Brand Devices [BD Settling Chambers]

• 30382904913305: BD Settling Chambers
• 30382904913299: BD Settling Chambers (96). Consumables for use on the PrepStain instrument.