Dell Precision 3620

GUDID 00849832013365

Dell Precision 3620

Leica Biosystems Richmond, Inc.

Desktop computer Desktop computer Desktop computer Desktop computer Desktop computer Desktop computer Desktop computer Desktop computer Desktop computer Desktop computer Desktop computer Desktop computer Desktop computer Desktop computer Desktop computer Desktop computer

• Primary Device ID: 00849832013365
• NIH Device Record Key: f61e7c2d-1670-44e1-8977-f45a601b7a3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dell Precision 3620
• Version Model Number: 23CPU1065
• Company DUNS: 082930884
• Company Name: Leica Biosystems Richmond, Inc.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com
• Phone: +1(800)5374669
• Email: tech.support@Leicabiosystems.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849832013365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042542

FDA Product Code

• JOY: DEVICE, AUTOMATED CELL-LOCATING

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: 2019-05-07
• Device Publish Date: 2018-05-07

Devices Manufactured by Leica Biosystems Richmond, Inc.

• 10849832025167 - Leica Biosystems: 2024-04-16 Taped Routine Cassettes, Pre-Load II , Taped, Yellow, 800 / Case
• 10849832025174 - Leica Biosystems: 2024-04-12 Taped Routine Cassettes, Pre-Load II , Taped, Green, 800 / Case
• 10849832025181 - Leica Biosystems: 2024-04-12 Taped Routine Cassettes, Pre-Load II , Taped, Pink, 800 / Case
• 00849832025436 - Leica Biosystems: 2024-04-12 WHITE PRELOAD II TAPED ROUTINE Cassettes (800/CS)
• 00849832013488 - WIN10 CPU UPGRADE FOR GSL(IN WARRANTY): 2019-11-18 WIN 10 CUP UPGRADE FOR GSL (IN WARRANTY)
• 00849832013495 - WIN10CPU UPGRADE FOR CAPTURE(INWARRANTY): 2019-11-18 WIN10 CPU UPGRADE FOR CAPTURE (IN WARRANTY)
• 00849832004233 - Leica Biosystems CytoVision ESI Citrix Server Image on USB HD Dist: 2019-10-07 Leica Biosystems CytoVision ESI Citrix Server Image on USB HD Dist
• 00849832005155 - Leica Biosystems CytoVision Removable Archive Device: 2019-10-07 Leica Biosystems Cytovision Removable Archive Device