ProVia 6

GUDID 20763000569857

GDWR 6PROV300HS PROVIA 5PK 300 HY ST

MEDTRONIC, INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 20763000569857
• NIH Device Record Key: 294e3dce-cb69-49d4-8201-d8645e92c895
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProVia 6
• Version Model Number: 6PROV300HS
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 300 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to organic solvents.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000569853 [Primary]
GS1	20763000569857 [Package]; Contains: 00763000569853; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140695

FDA Product Code

• DQX: Wire, guide, catheter

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: 2022-02-14
• Device Publish Date: 2022-02-06

On-Brand Devices [ProVia 6]

• 20643169453092: GDWR 6PROV180HS ProVia 5pk 180 HY ST
• 20643169453085: GDWR 6PROV180SS ProVia 5pk 180 Si ST
• 00643169453074: GDWR 6PROV300HS ProVia 5pk 300 HY ST
• 20643169453061: GDWR 6PROV300SS ProVia 5pk 300 Si ST
• 20763000569871: GDWR 6PROV180HS PROVIA 5PK 180 HY ST
• 20763000569864: GDWR 6PROV180SS PROVIA 5PK 180 SI ST
• 20763000569857: GDWR 6PROV300HS PROVIA 5PK 300 HY ST
• 20763000569840: GDWR 6PROV300SS PROVIA 5PK 300 SI ST