COMPASS STAINER ASY-05576

GUDID 15420045513853

Hologic, Inc.

Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD

• Primary Device ID: 15420045513853
• NIH Device Record Key: 4450eafd-59ad-419a-bae8-8f5eb86bdd86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPASS STAINER
• Version Model Number: SLIDE STAINER, AUTOMATED
• Catalog Number: ASY-05576
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 16 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 740 Millimeter of Mercury and 790 Millimeter of Mercury
• Storage Environment Atmospheric Pressure: Between 70 Millimeter of Mercury and 80 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 740 Millimeter of Mercury and 790 Millimeter of Mercury
• Storage Environment Atmospheric Pressure: Between 70 Millimeter of Mercury and 80 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 740 Millimeter of Mercury and 790 Millimeter of Mercury
• Storage Environment Atmospheric Pressure: Between 70 Millimeter of Mercury and 80 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 740 Millimeter of Mercury and 790 Millimeter of Mercury
• Storage Environment Atmospheric Pressure: Between 70 Millimeter of Mercury and 80 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 740 Millimeter of Mercury and 790 Millimeter of Mercury
• Storage Environment Atmospheric Pressure: Between 70 Millimeter of Mercury and 80 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 740 Millimeter of Mercury and 790 Millimeter of Mercury
• Storage Environment Atmospheric Pressure: Between 70 Millimeter of Mercury and 80 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 740 Millimeter of Mercury and 790 Millimeter of Mercury
• Storage Environment Atmospheric Pressure: Between 70 Millimeter of Mercury and 80 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045513853 [Primary]

FDA Product Code

• KPA: Slide stainer, automated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-08
• Device Publish Date: 2020-09-30

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