Test Thrombin Reagent OWHM13

GUDID 00842768012716

Determination of thrombin time in human plasma

Siemens Healthcare Diagnostics Products GmbH

Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting Thrombin time (TT) IVD, kit, clotting

• Primary Device ID: 00842768012716
• NIH Device Record Key: 4fe51ca3-4747-412d-bce7-7565e032d20c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Test Thrombin Reagent
• Version Model Number: 10446598
• Catalog Number: OWHM13
• 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)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842768012716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930157

FDA Product Code

• GJA: TEST, THROMBIN TIME

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 [Test Thrombin Reagent]

• 00842768012716: Determination of thrombin time in human plasma
• 00630414639635: Determination of thrombin time in human plasma