Dimension Vista Flex Reagent Cartridge OXY K5098

GUDID 00630414295053

Urine Oxycodone Screen Flex reagent cartridge, 120 tests

Siemens Healthcare Diagnostics Inc.

Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA) Oxycodone IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00630414295053
• NIH Device Record Key: b28b39cb-685a-4de5-8b16-8866ded6ee68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dimension Vista Flex Reagent Cartridge OXY
• Version Model Number: 11533384
• Catalog Number: K5098
• Company DUNS: 005088112
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: true
• 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)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414287263 [Primary]
GS1	00630414295053 [Unit of Use]

FDA Product Code

• DJG: Enzyme immunoassay, opiates

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-18
• Device Publish Date: 2021-04-09

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

• 00630414313450 - Atellica CH Billirubin Calibrator (BILI CAL): 2024-04-11 Atellica CH Bilirubin Calibrator (BILI CAL)
• 00630414317427 - Clinistix UTI Test Strips: 2024-02-29 Test strips for urinary tract infection
• 00630414626963 - ADVIA Centaur NT-PBNPII (PBNPII): 2024-02-13 PBNPII - ADVIA Centaur - MCM Set
• 00630414626970 - ATELLICA IM NT-PBNPII (PBNPII): 2024-02-13 PBNPII - ATELLICA IM - MCM Set
• 00630414284927 - ADVIA Centaur PBNPII: 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 100T
• 00630414284934 - ADVIA Centaur PBNPII: 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 500T
• 00630414284941 - Atellica IM PBNPII: 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 100T
• 00630414284958 - Atellica IM PBNPII: 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 500T