CELLTRACKS AUTOPREP 9541

GUDID 10888385000665

CELLTRACKS AUTOPREP - EU ROHS Compliant

MENARINI SILICON BIOSYSTEMS, INC.

Specimen processing instrument IVD, automated

• Primary Device ID: 10888385000665
• NIH Device Record Key: 2efa8255-9c11-4d52-bb3d-1bc5bfb7975d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CELLTRACKS AUTOPREP
• Version Model Number: 9541
• Catalog Number: 9541
• Company DUNS: 057722858
• Company Name: MENARINI SILICON BIOSYSTEMS, 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: 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: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com
• Phone: 2153468312
• Email: jclay@siliconbiosystems.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888385000665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122821

FDA Product Code

• NQI: System, Immunomagnetic, Circulating Cancer Cell, Enumeration

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: 2020-07-20
• Device Publish Date: 2020-07-10

On-Brand Devices [CELLTRACKS AUTOPREP]

• 10888385000665: CELLTRACKS AUTOPREP - EU ROHS Compliant
• 10888385000610: AutoPrep Instrument- Refurbished
• 10888385000078: CellTracks AutoPrep Instrument Buffer
• 10888385000061: AutoPrep Instrument