Corvac 8881302072

GUDID 10884521742444

True content to be populated as part of rebranding

Cardinal Health, Inc.

Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive Non-evacuated blood collection tube IVD, no additive

• Primary Device ID: 10884521742444
• NIH Device Record Key: 1cc1ca16-dfbc-45c7-9dd5-9779c5892561
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Corvac
• Version Model Number: 8881302072
• Catalog Number: 8881302072
• Company DUNS: 080935429
• Company Name: Cardinal Health, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521742444 [Package]; Contains: 20884521742441; Package: CASE [5 Units]; In Commercial Distribution
GS1	20884521742441 [Primary]
GS1	30884521742448 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915213

FDA Product Code

• GIM: Tubes, vacuum sample, with anticoagulant

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-12
• Device Publish Date: 2019-06-04

On-Brand Devices [Corvac]

• 20884527003164: Integrated Serum Separator Tube,Red/Gray Stopper, 9.0 mL Draw
• 10884527003266: Integrated Serum Separator Tube,Plastic, Red/Gray Stopper, 8.5 mL Draw
• 30884527003253: Integrated Serum Separator Tube with Thrombin,Red/Yellow Stopper, 6.0 mL Draw
• 30884527003246: Integrated Serum Separator Tube with Thrombin,Red/Yellow Stopper, 9.0 mL Draw
• 10884527003235: Integrated Serum Separator Tube,Plastic, Red/Gray Stopper, 8.0 mL Draw
• 10884527003204: Integrated Serum Separator Tube,Red/Gray Stopper, 12.5 mL Draw
• 10884527003198: Integrated Serum Separator Tube,Red/Gray Stopper, 6.0 mL Draw
• 30884527003185: Integrated Serum Separator Tube,Red/Gray Stopper, 4.0 mL Draw
• 10884527003174: Integrated Serum Separator Tube,Transport, Red/Gray Stopper, 8.5 mL Draw
• 10884521742420: True content to be populated as part of rebranding
• 10884521742444: True content to be populated as part of rebranding
• 10884521742468: True content to be populated as part of rebranding