FREESTYLE®

GUDID 00643169008137

VLV FR995-27 FREESTYLE AOR US TEMP IND

MEDTRONIC, INC.

Aortic heart valve bioprosthesis

• Primary Device ID: 00643169008137
• NIH Device Record Key: 982f1729-5da6-440c-802b-18d9e352e501
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREESTYLE®
• Version Model Number: FR995-27
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169008137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970031

FDA Product Code

• LWR: heart-valve, non-allograft tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [FREESTYLE®]

• 00613994348982: VALVE FR995-29 FREESTYLE US NNA
• 00613994348975: VALVE FR995-27 FREESTYLE US NNA
• 00643169008144: VLV FR995-29 FREESTYLE AOR US TEMP IND
• 00643169008137: VLV FR995-27 FREESTYLE AOR US TEMP IND
• 00643169002418: VLV 995MS21 FREESTYLE MS US TEMP IND
• 00643169002395: VLV 995MS19 FREESTYLE MS US TEMP IND
• 00643169002302: VLV 995CS27 FREESTYLE CS US TEMP IND
• 00643169002289: VLV 995CS25 FREESTYLE CS US TEMP IND
• 00643169002265: VLV 995CS23 FREESTYLE CS US TEMP IND
• 00643169002241: VLV 995CS21 FREESTYLE CS US TEMP IND
• 00643169002227: VLV 995CS19 FREESTYLE CS US TEMP IND
• 00643169002197: VLV FR995-29 FREESTYLE AOR NNA US TEMP I
• 00643169002173: VLV FR995-27 FREESTYLE AOR NNA US TEMP I
• 00643169002159: VLV FR995-25 FREESTYLE AOR US TEMP IND
• 00643169002135: VLV FR995-23 FREESTYLE AOR US TEMP IND
• 00643169002111: VLV FR995-21 FREESTYLE AOR US TEMP IND
• 00643169002098: VLV FR995-19 FREESTYLE AOR US TEMP IND
• 00643169002074: VLV 995MS29 FREESTYLE MS US TEMP IND
• 00643169002050: VLV 995MS27 FREESTYLE MS US TEMP IND
• 00643169002036: VLV 995MS25 FREESTYLE MS US TEMP IND
• 00643169002012: VLV 995MS23 FREESTYLE MS US TEMP IND
• 00681490816465: VALVE FR995-29 FREESTYLE AOR US
• 00681490265942: VALVE FR995-27 FREESTYLE AOR US
• 00681490265904: VALVE FR995-23 FREESTYLE AOR US
• 00681490265898: VALVE FR995-21 FREESTYLE AOR US
• 00681490219198: VALVE 995CS27 FREESTYLE CS US
• 00681490219150: VALVE 995CS25 FREESTYLE CS US
• 00681490219112: VALVE 995CS23 FREESTYLE CS US
• 00681490219075: VALVE 995CS21 FREESTYLE CS US
• 00681490219037: VALVE 995CS19 FREESTYLE CS US
• 00721902316197: VALVE 995MS29 FREESTYLE MS US
• 00721902316180: VALVE 995MS27 FREESTYLE MS US
• 00721902316173: VALVE 995MS25 FREESTYLE MS US
• 00721902316166: VALVE 995MS23 FREESTYLE MS US
• 00721902316159: VALVE 995MS21 FREESTYLE MS US
• 00721902316142: VALVE 995MS19 FREESTYLE MS US
• 10681490265918: VALVE FR99525 FREESTYLE AOR US
• 10681490265888: VALVE FR995-19 FREESTYLE AOR US