DxTerity™ Angio-Kit

GUDID 20643169738274

CATH AKSTAN501 DXT 5F 5PK ANGIO STD KIT

MEDTRONIC, INC.

Angiographic catheter, single-use Angiographic catheter, single-use

• Primary Device ID: 20643169738274
• NIH Device Record Key: 8ee6b4ce-1489-4124-9ae2-6355d9cd7e39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxTerity™ Angio-Kit
• Version Model Number: AKSTAN501
• 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: 5 French
• Catheter Gauge: 5 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	00643169738270 [Primary]
GS1	20643169738274 [Package]; Contains: 00643169738270; 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™ Angio-Kit]

• 20643169738304: CATH AKSTAN602 DXT 6F 5PK ANGIO STD KIT
• 20643169738298: CATH AKSTAN601 DXT 6F 5PK ANGIO STD KIT
• 20643169738281: CATH AKSTAN502 DXT 5F 5PK ANGIO STD KIT
• 20643169738274: CATH AKSTAN501 DXT 5F 5PK ANGIO STD KIT