Atellica IM CKMB Calibrator 10995532

GUDID 00630414598598

CKMB Calibrator Atellica IM - CAL (2PK) 2 x 2 x 5.0mL

Siemens Healthcare Diagnostics Inc.

Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

• Primary Device ID: 00630414598598
• NIH Device Record Key: 774fa0f2-c966-4a1a-9a2c-d8a4e8c49b2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atellica IM CKMB Calibrator
• Version Model Number: 10995532
• Catalog Number: 10995532
• 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	00630414190938 [Unit of Use]
GS1	00630414598598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K962126

FDA Product Code

• JHS: DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES

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: 2018-02-06

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