Atellica IM BR Calibrator 10995515

GUDID 00630414598420

BR Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL

Siemens Healthcare Diagnostics Inc.

Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator Cancer antigen 27-29 (CA27-29) IVD, calibrator

• Primary Device ID: 00630414598420
• NIH Device Record Key: 5229ea07-a601-475d-ab14-636cfe620cdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atellica IM BR Calibrator
• Version Model Number: 10995515
• Catalog Number: 10995515
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 2
• 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: 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414190846 [Unit of Use]
GS1	00630414598420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982680

FDA Product Code

• MOI: SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

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: 2017-12-22

On-Brand Devices [Atellica IM BR Calibrator]

• 00630414598420: BR Calibrator Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
• 00630414294056: BR Calibrator - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL