Atellica IM PBNPII 11203761

GUDID 00630414284941

NT-proBNPII (PBNPII) - Atellica IM - RGT - 100T

Siemens Healthcare Diagnostics Inc.

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00630414284941
• NIH Device Record Key: 48c19c86-04d6-44d9-a4c1-3b249949df7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atellica IM PBNPII
• Version Model Number: 11203761
• Catalog Number: 11203761
• 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: 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
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414284941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220265

FDA Product Code

• NBC: Test, natriuretic peptide

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: 2024-02-12
• Device Publish Date: 2024-02-02

On-Brand Devices [Atellica IM PBNPII]

• 00630414284958: NT-proBNPII (PBNPII) - Atellica IM - RGT - 500T
• 00630414284941: NT-proBNPII (PBNPII) - Atellica IM - RGT - 100T