Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 1 9S529UL

GUDID 00630414601137

Syva® Emit® II Plus Buprenorphine Calibrator and Control, Level 1

Siemens Healthcare Diagnostics Inc.

Multiple drugs of abuse IVD, calibrator

• Primary Device ID: 00630414601137
• NIH Device Record Key: bd77ca3c-1d1a-4909-84f1-5cc36b404f1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 1
• Version Model Number: 10720049
• Catalog Number: 9S529UL
• Company DUNS: 005088112
• 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(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: XX@XX.XX
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)227-8994
• 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
• 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	00630414601137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150606

FDA Product Code

• DLJ: CALIBRATORS, DRUG SPECIFIC

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

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