Atellica IM CKMB 10995530

GUDID 00630414598574

CKMB - Atellica IM - RGT 100T

Siemens Healthcare Diagnostics Inc.

Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00630414598574
• NIH Device Record Key: 2b1e0f42-b339-4cda-aee6-0d52df07af25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atellica IM CKMB
• Version Model Number: 10995530
• Catalog Number: 10995530
• 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: 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

• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414598574 [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: 2017-12-22

On-Brand Devices [Atellica IM CKMB]

• 00630414598581: CKMB Atellica IM - RGT 500T
• 00630414598574: CKMB - Atellica IM - RGT 100T
• 00630414294148: CKMB - Atellica IM - RGT 500T