Abre™

GUDID 00643169796263

STENT AB9U12150090 ABRE V01

MEDTRONIC, INC.

Iliofemoral vein stent

• Primary Device ID: 00643169796263
• NIH Device Record Key: 7f7fa03e-5d18-4167-b7e4-5c23aec79e89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abre™
• Version Model Number: AB9U12150090
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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

• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
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• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Stent Length: 150 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposing the Abre system to water, sunlight, extreme temperatures, and high humidity during storage. Store the Abre system under controlled room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169796263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200026

FDA Product Code

• QAN: Stent, iliac vein

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: 2020-11-09
• Device Publish Date: 2020-11-01

On-Brand Devices [Abre™]

• 00643169796478: STENT AB9U20150090 ABRE V01
• 00643169796461: STENT AB9U20120090 ABRE V01
• 00643169796454: STENT AB9U20100090 ABRE V01
• 00643169796447: STENT AB9U20080090 ABRE V01
• 00643169796430: STENT AB9U20060090 ABRE V01
• 00643169796423: STENT AB9U18150090 ABRE V01
• 00643169796416: STENT AB9U18120090 ABRE V01
• 00643169796409: STENT AB9U18100090 ABRE V01
• 00643169796393: STENT AB9U18080090 ABRE V01
• 00643169796386: STENT AB9U18060090 ABRE V01
• 00643169796379: STENT AB9U16150090 ABRE V01
• 00643169796362: STENT AB9U16120090 ABRE V01
• 00643169796355: STENT AB9U16100090 ABRE V01
• 00643169796348: STENT AB9U16080090 ABRE V01
• 00643169796331: STENT AB9U16060090 ABRE V01
• 00643169796324: STENT AB9U14150090 ABRE V01
• 00643169796317: STENT AB9U14120090 ABRE V01
• 00643169796300: STENT AB9U14100090 ABRE V01
• 00643169796294: STENT AB9U14080090 ABRE V01
• 00643169796287: STENT AB9U14060090 ABRE V01
• 00643169796263: STENT AB9U12150090 ABRE V01
• 00643169796256: STENT AB9U12120090 ABRE V01
• 00643169796249: STENT AB9U12100090 ABRE V01
• 00643169796232: STENT AB9U12080090 ABRE V01
• 00643169796225: STENT AB9U12060090 ABRE V01
• 00643169796201: STENT AB9U10150090 ABRE V01
• 00643169796195: STENT AB9U10120090 ABRE V01
• 00643169796188: STENT AB9U10100090 ABRE V01
• 00643169796171: STENT AB9U10080090 ABRE V01
• 00643169796164: STENT AB9U10060090 ABRE V01
• 00643169796157: STENT AB9U10040090 ABRE V01