N Diluent OUMT65

GUDID 00842768011436

Solution for preparing dilutions for immunochemical determinations with the BN II or BN ProSpec® Systems

Siemens Healthcare Diagnostics Products GmbH

Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD, automated/semi-automated system Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD

• Primary Device ID: 00842768011436
• NIH Device Record Key: 8a8535f2-322b-400c-9a34-baf78d94bef3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N Diluent
• Version Model Number: 10446457
• Catalog Number: OUMT65
• Company DUNS: 388240673
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• 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(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: XX@XX.XX
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)664-3822
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842768011436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K860894

FDA Product Code

• CFN: METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)

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

On-Brand Devices [N Diluent]

• 00842768030239: Solution for preparing dilutions for immunochemical determinations with the Dimension Vista® Sy
• 00842768011436: Solution for preparing dilutions for immunochemical determinations with the BN II or BN ProSpec�