DCA® Systems Microalbumin/Creatinine Capillary holders and plungers 10888739

GUDID 00630414027364

A urine collection tube holder and plunger; to be used with DCA® Systems Microalbumin/Creatinine Reagent Cartridge.

Siemens Healthcare Diagnostics Inc.

Microcapillary blood collection tube IVD, no additive Microcapillary blood collection tube IVD, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive Capillary blood collection tube IVD, no additive

• Primary Device ID: 00630414027364
• NIH Device Record Key: 64fe0088-bbef-4ebe-bf7c-563b11a48af0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DCA® Systems Microalbumin/Creatinine Capillary holders and plungers
• Version Model Number: 10888739
• Catalog Number: 10888739
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 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: 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
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414027364 [Primary]
GS1	00630414211022 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963142

FDA Product Code

• JIR: INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

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: 2017-03-01

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

• 00630414305028 - Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2): 2024-06-19 Atellica CH High Sensitivity C-Reactive Protein (hCRP2) Reagent
• 00630414624488 - ADVIA Centaur TSH3-Ultra II: 2024-05-30 TSH3-ULII ADVIA Centaur - RGT 500T
• 00630414624501 - ADVIA Centaur TSH3-Ultra II: 2024-05-30 TSH3-ULII ADVIA Centaur - RGT (REF) 2500T
• 00630414624518 - Atellica IM TSH3-Ultra II: 2024-05-30 TSH3-ULII Atellica IM - RGT 110T
• 00630414624525 - Atellica IM TSH3-Ultra II: 2024-05-30 TSH3-ULII Atellica IM – RGT 550T
• 00630414624532 - Atellica IM TSH3ULII MCM set: 2024-05-30 TSH3-ULII Atellica IM - Consumable MCM Set
• 00630414624693 - Atellica IM TSH3-Ultra II: 2024-05-30 TSH3-ULII Atellica IM - RGT (REF) 2750T
• 00630414624709 - ADVIA Centaur TSH3ULII MCM SET: 2024-05-30 TSH3-ULII ADVIA Centaur - Consumable MCM Set