Stratus® CS STAT Fluorometric Analyzer Cannula CCANBD

GUDID 00842768004438

For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tubes, with HEMOGARD® closure, to be used on the Stratus® CS STAT Fluorometric Analyzer.

Siemens Healthcare Diagnostics Inc.

Fluorescent immunoassay analyser IVD, laboratory, semi-automated

• Primary Device ID: 00842768004438
• NIH Device Record Key: 37550c39-7394-43ba-8cdf-5b0c2222ed8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratus® CS STAT Fluorometric Analyzer Cannula
• Version Model Number: 10445063
• Catalog Number: CCANBD
• Company DUNS: 005088112
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 100
• 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: 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)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414009780 [Unit of Use]
GS1	00842768004438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984067

FDA Product Code

• JHX: FLUOROMETRIC 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: 2016-09-24

On-Brand Devices [Stratus® CS STAT Fluorometric Analyzer Cannula]

• 00842768004445: Stratus® CS STAT Fluorometric Analyzer Sarstedt cannula holds the stoppered tube in the sample
• 00842768004438: For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tubes, with HEMOGAR