DxTerity™ TRA Angio-Kit

GUDID 20643169738359

CATH AKUNIV601 DXT 6F 5PK ANGIO RAD KIT

MEDTRONIC, INC.

Angiographic catheter, single-use

• Primary Device ID: 20643169738359
• NIH Device Record Key: da09eff1-5b41-4291-980e-d1ec5f9fe57f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxTerity™ TRA Angio-Kit
• Version Model Number: AKUNIV601
• 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

Device Dimensions

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store diagnostic catheters in a cool, dry, and dark area. Do not expose diagnostic catheters to UV light
• Special Storage Condition, Specify: Between 0 and 0 *Store diagnostic catheters in a cool, dry, and dark area. Do not expose diagnostic catheters to UV light

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169738355 [Primary]
GS1	20643169738359 [Package]; Contains: 00643169738355; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161287

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

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: 2017-09-30

On-Brand Devices [DxTerity™ TRA Angio-Kit]

• 20643169738380: CATH AKUNIV604 DXT 6F 5PK ANGIO RAD KIT
• 20643169738373: CATH AKUNIV603 DXT 6F 5PK ANGIO RAD KIT
• 20643169738366: CATH AKUNIV602 DXT 6F 5PK ANGIO RAD KIT
• 20643169738359: CATH AKUNIV601 DXT 6F 5PK ANGIO RAD KIT
• 20643169738342: CATH AKUNIV504 DXT 5F 5PK ANGIO RAD KIT
• 20643169738335: CATH AKUNIV503 DXT 5F 5PK ANGIO RAD KIT
• 20643169738328: CATH AKUNIV502 DXT 5F 5PK ANGIO RAD KIT
• 20643169738311: CATH AKUNIV501 DXT 5F 5PK ANGIO RAD KIT