GUDID 20613994936138

CATH 5A0062 SS 5PK 5F ANG KIT W/STR PG

MEDTRONIC, INC.

Angiographic catheter, single-use

• Primary Device ID: 20613994936138
• NIH Device Record Key: fc80459e-cac7-4cf9-be60-dca42e336c95
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5A0062
• 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 catheters in a cool, dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Store catheters in a cool, dry area.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994936134 [Primary]
GS1	20613994936138 [Package]; Contains: 00613994936134; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932092

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: 2016-06-13

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