ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC T01-3626-52

GUDID 00630414222950

IVD Complete Blood Count Kit CN-FREE

Siemens Healthcare Diagnostics Inc.

Full blood count IVD, kit, cell count

• Primary Device ID: 00630414222950
• NIH Device Record Key: 15c4f866-161b-4511-914c-465532fbb9bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC
• Version Model Number: 10341169
• Catalog Number: T01-3626-52
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414222950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971998

FDA Product Code

• GKL: COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)

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: 2016-09-24

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