ThinPrep 2000 Processor PRD-04184

GUDID 15420045507005

Hologic, Inc.

Microscope slide maker IVD

• Primary Device ID: 15420045507005
• NIH Device Record Key: 9953c673-08f3-4fe4-b2c1-a10f386acfbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThinPrep 2000 Processor
• Version Model Number: ThinPrep 2000 Processor
• Catalog Number: PRD-04184
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 20 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between -28 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045507005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950039

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-10

On-Brand Devices [ThinPrep 2000 Processor]

• 15420045507005: ThinPrep 2000 Processor
• 15420045500839: ThinPrep 2000 Processor